MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2015-11-04 for HEART CATH PACK 89-7425 manufactured by Deroyal Industries, Inc..
[30458952]
Root cause analysis: the sample was not returned to deroyal for evaluation. Therefore, a true root cause cannot be determined. Potential root causes have been identified but are not limited to the following: mishandling of the device caused a crack that was undetected prior to use; or vendor manufacturing related issue. Corrective action and/or systemic correction action taken: due to the investigation and root cause determination, a corrective action has not been taken. Investigation summary: a complaint (call (b)(4)) was received reporting that a heart cath pack (part number 89-7425, lot number 38923207) contained a syringe that cracked during administration of medication. A sample was not returned for evaluation. Without a sample, a true root cause cannot be determined. It cannot be confirmed if the issue occurred due to the raw material supplier, manufacturing, or end user. Deroyal made multiple attempts to obtain the sample for evaluation, but a sample was never received. The bill of materials for the finished good contained multiple syringes. Therefore, the qc complaint specialist followed up with the reporting customer, who responded identifying the issue occurred with the 10cc luer lock syringe (raw material(b)(4)). Using the lot mapping feature in (b)(4), the qc complaint specialist confirmed that lot number 39823207 of the heart cath pack contained lot number 15135071 of the raw material 10cc luer lock syringe. The work order was reviewed for discrepancies that may have contributed to the reported issue, but no discrepancies were identified. Multiple vendors supply raw material (b)(4) to deroyal. Quality control at the manufacturing facility identified the supplier as (b)(4). The 2013 to 2015 supplier corrective action request (scar) and supplier notification letter (snl) logs were reviewed for similar complaints. No similar complaints were identified for the raw material or failure mode reported. Due to the failure reported, the qc complaint specialist issued a scar to (b)(4) for notification of the report. Deroyal has not received a response to the scar. The complaint investigation will be reviewed for updates when the response is received. Deroyal has sold (b)(4) each of raw material (b)(4) from 2013 to present. The complaint to sales ratio is (b)(4). Deroyal will continue to monitor trends for this failure and will recognize in the future if it transitions into a recurring issue. Preventive action: due to the investigation and root cause determination, a preventive action has not been taken. The investigation is complete. If new and critical information is received, this report will be updated. Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[30458953]
A 10 ml syringe inside the pack cracked when medication was pushed. The procedure was delayed while they had to change syringes and redraw medication. No injury was reported medication was wasted from cracked syringe.
Patient Sequence No: 1, Text Type: D, B5
[55353368]
Root cause analysis: the raw material in which the reported issue occurred is supplied to deroyal by (b)(4) in response to a supplier corrective action response (scar) received august 12, 2016, (b)(4) identified the root cause of cracking-related failures to be a packaging-related issue. (b)(4) stated the syringes are shipped bulk non-sterile in cases of (b)(4) units. There have been reports in the past of the product cracking upon receipt. (b)(4) believes this issue is related to the packaging, which is making the product weak during the shipping process. Corrective action: in its scar response, (b)(4) stated the product now is being packaged in lower quantities of (b)(4) or less and is being placed into smaller quantities in the case. Investigation summary: a complaint (call 3(b)(4)) was received reporting that a heart cath pack (part number 89-7425, lot number 38923207) contained a syringe that cracked during administration of medication. The bill of materials for the finished good contained multiple syringes. Therefore, the qc complaint specialist followed up with the reporting customer, who responded identifying the issue occurred with the 10cc luer lock syringe (raw material (b)(4)). Using the lot mapping feature in jd edwards, the qc complaint specialist confirmed that lot number 39823207 of the heart cath pack contained lot number 15135071 of the raw material 10cc luer lock syringe. Multiple vendors supply raw material (b)(4) to deroyal. Quality control at the manufacturing facility identified the supplier as (b)(4). Evaluation of the 2015 to 2016 scar log identifies multiple reports of cracked syringes supplied by (b)(4). A scar request was issued to (b)(4), and a response was received august 18, 2016. A sample was not returned for the reported incident. The work order was reviewed for discrepancies that may have contributed to the reported issue, but no discrepancies were identified. Deroyal has sold (b)(4) each of raw material (b)(4) from 2013 to present. (b)(4). Deroyal will continue to monitor postmarket feedback for the reported issue and verification of the supplier's actions. Preventive action: due to the investigation and root cause determination, a preventive action has not been taken. The investigation is complete. If new and critical information is received, this report will be updated. Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[55353369]
A 10 ml syringe inside the pack cracked when medication was pushed. The procedure was delayed while they had to change syringes and redraw medication. No injury was reported medication was wasted from cracked syringe.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005011024-2015-00011 |
| MDR Report Key | 5202336 |
| Report Source | USER FACILITY |
| Date Received | 2015-11-04 |
| Date of Report | 2016-09-07 |
| Date of Event | 2015-09-09 |
| Date Mfgr Received | 2015-10-06 |
| Device Manufacturer Date | 2015-08-18 |
| Date Added to Maude | 2015-11-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SARAH BENNETT |
| Manufacturer Street | 200 DEBUSK LANE |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8653626112 |
| Manufacturer G1 | DEROYAL LNDUSTRIES, INC. |
| Manufacturer Street | 1501 EAST CENTRAL AVENUE |
| Manufacturer City | LAFOLLETTE TN 37766 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 37766 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEART CATH PACK |
| Generic Name | ANGIOGRAPHY/ANGIOPLASTY KIT |
| Product Code | OEQ |
| Date Received | 2015-11-04 |
| Catalog Number | 89-7425 |
| Lot Number | 39823207 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL INDUSTRIES, INC. |
| Manufacturer Address | 1501 EAST CENTRAL AVENUE LAFOLLETTE TN 37766 US 37766 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-11-04 |