MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-27 for CATH LAB PACK 89-7194 manufactured by Deroyal Industries, Inc..
[44493034]
Investigation summary: an internal complaint (call (b)(4)) was received regarding a cath lab pack (finished good (b)(4)) that contained a defective scalpel (raw material (b)(4)). The end user reported that the scalpel "had blood inside the protective cap. " a return kit has been sent to the customer and it is anticipated that the sample will be returned for evaluation. As of the date of this report, the sample had not been returned for evaluation. The scalpel contained within the pack is supplied to (b)(4). Thus, a supplier corrective action request (scar) was issued to (b)(4) on april 4, 2016, and is due may 16, 2016. This due date is exactly 30 working days from the date the scar was issued. The investigation is incomplete at this time. If new and critical information is received, this report will be updated.
Patient Sequence No: 1, Text Type: N, H10
[44493035]
The scalpel had blood inside the protective cap. This was discovered before the case began.
Patient Sequence No: 1, Text Type: D, B5
[48684644]
Root cause: the scalpel contained within the pack is supplied to deroyal by (b)(4). Thus, a supplier corrective action request (scar) was issued to aspen. In its response, (b)(4) stated inspection of the returned sample confirmed foreign matter present on the protective cover. A root cause analysis was performed, and it was determined that the most probable root cause could be attributed to method or man. Method: this would be the root cause if gloves were not being used correctly in production. Man: affected personnel did not follow the correct process of accident notification. There have been no previous reports due to this incident; therefore, the manufacturer has identified this as an isolated event. Corrective action: (b)(4) stated in its scar response the customer complaint defect was reviewed with the affected packaging personnel and quality inspectors. A review and update to the work instructions was made to clarify the glove type to be utilized in production. Ehs awareness was presented to affected personnel may 2, 2016. Investigation summary: (b)(4). The defective sample was returned may 2, 2016, to deroyal. Contamination was identified, and the sample was forward to the manufacturer, (b)(4), for evaluation. (b)(4). Deroyal will continue to monitor post market feedback and will recognize in the future if the reported issue of contamination transitions from an isolated report to a recurring issue. Preventive action: according to (b)(4), 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
[48684645]
The scalpel had blood inside the protective cap. This was discovered before the case began.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005011024-2016-00004 |
| MDR Report Key | 5610881 |
| Date Received | 2016-04-27 |
| Date of Report | 2016-06-30 |
| Date of Event | 2016-03-30 |
| Date Mfgr Received | 2016-03-30 |
| Date Added to Maude | 2016-04-27 |
| 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 LAB PACK |
| Generic Name | ANGIOGRAPHY KIT |
| Product Code | OEQ |
| Date Received | 2016-04-27 |
| Returned To Mfg | 2016-05-02 |
| Catalog Number | 89-7194 |
| Lot Number | 41168002 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2016-04-27 |