MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-08-19 for CATH PACK CSM 89-6896 manufactured by Deroyal Industries, Inc..
[52734630]
An internal complaint (call (b)(4)) was received indicating that a cath pack (finished good (b)(4), lot number 41167851) contained syringes that have been cracking during use, allowing blood to squirt onto the staff. A sample was reported to be available, but as of the date of this report, it has not been returned. The work order was reviewed for discrepancies that may have contributed to the reported incident. None were identified. There are multiple syringes contained within the finished good kit. The reporting customer was contacted to identify the correct raw material. The customer confirmed the correct raw material is a 10cc syringe raw material (b)(4). This syringe is supplied to deroyal by (b)(4). Therefore, a supplier corrective action request was submitted to (b)(4) on (b)(6) 2016. A response has not been received at this time. The investigation is ongoing at this time. When new and critical information is received, this report will be updated.
Patient Sequence No: 1, Text Type: N, H10
[52734631]
Some of the syringes in the pack have been cracking during use. This has caused situations in which a staff member pushes the barrel of the syringe to inject not knowing that the syringe is cracked, resulting in blood squirting out on the staff. The user facility considers this a safety concern.
Patient Sequence No: 1, Text Type: D, B5
[55135406]
Root cause: the raw material in which the reported issue occurred is supplied to deroyal by (b)(4). Therefore, a supplier corrective action response (scar) was submitted to (b)(4). In its response, (b)(4) identified the root cause as a packaging-related issue. (b)(4) stated the syringes are shipped bulk non-sterile in cases of 1,000 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 500 or less and is being placed into smaller quantities in the case. Investigation summary: an internal complaint ((b)(4)) was received indicating that a cath pack (finished good 89-6896, lot number 41167851) contained syringes that have been cracking during use, allowing blood to squirt onto the staff. There are multiple syringes contained within the finished good kit. The reporting customer was contacted to identify the correct raw material. The customer confirmed the correct raw material is a 10cc syringe (raw material 5-20055). This syringe is supplied to deroyal (b)(4). A review of the 2015-2016 scar log identified previous reports for cracked syringes supplied by (b)(4). Therefore, a scar was submitted to (b)(4) on august 12, 2016. A response was received august 18. The actual sample was received august 19 and (b)(4) was notified regarding its availability. The work order was reviewed for discrepancies that may have contributed to the reported incident. None were identified. Deroyal will continue to monitor postmarket feedback for the reported issue and verification of the supplier's actions. Preventive action: a preventive action has not been taken. The investigation is complete at this time. If new and critical information is received, this report will be updated.
Patient Sequence No: 1, Text Type: N, H10
[55135407]
Some of the syringes in the pack have been cracking during use. This has caused situations in which a staff member pushes the barrel of the syringe to inject not knowing that the syringe is cracked, resulting in blood squirting out on the staff. The user facility considers this a safety concern.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005011024-2016-00021 |
| MDR Report Key | 5890275 |
| Report Source | USER FACILITY |
| Date Received | 2016-08-19 |
| Date of Report | 2016-09-07 |
| Date of Event | 2016-07-22 |
| Date Mfgr Received | 2016-07-22 |
| Date Added to Maude | 2016-08-19 |
| 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 INDUSTRIES, 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 | CATH PACK CSM |
| Generic Name | ANGIOGRAPHY/ANGIOPLASTY KIT |
| Product Code | OEQ |
| Date Received | 2016-08-19 |
| Returned To Mfg | 2016-08-19 |
| Catalog Number | 89-6896 |
| Lot Number | 41167851 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2016-08-19 |