MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-10-22 for PERCUTANEOUS TRAY 89-5525 manufactured by Deroyal Industries, Inc..
[126100767]
Root cause: in its scar response, (b)(4) stated that every bundle of sponges goes through an automatic counting machine for piece count verification. It is possible the reported incident is the result of a manufacturing error in which an employee accidentally retained the wrong piece count bundle instead of rejecting it. Corrective action: the vendor reported in its scar that training on the piece count machine operation procedure and additional inspections will be performed. Investigation summary: an internal complaint ((b)(4)) was received indicating that a convenience kit (part 89-5525, lot 47941027) contained a pack of lap sponges with seven pieces instead of five. The end user reported this incident to the fda. The defective sample was not returned for evaluation. The deroyal complaint investigator reviewed the work order for possible discrepancies that may have contributed to the reported event. No discrepancies were identified. The bill of materials was reviewed and it was determined the affected raw material component was part 5-1819, a lap sponge pack supplied to deroyal by (b)(4). This pack comes to deroyal in bulk in bundled stacks of five. Deroyal employees do not unbundle these stacks at any point during the kit assembly process. Therefore, the reported non-conformance was determined to be a vendor issue. The supplier corrective action request (scar) and supplier notification letter logs were reviewed for the years 2016-2018 for similar issues. Previous issues similar to the reported complaint were identified, and a new scar was issued to (b)(4). A response has been received and accepted by deroyal's complaint investigator. Deroyal will continue to monitor post-market feedback and will recognize in the future if the issue reoccurs.
Patient Sequence No: 1, Text Type: N, H10
[126100768]
The convenience kit contained seven sponges when there only should have been five.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005011024-2018-00006 |
| MDR Report Key | 7990250 |
| Report Source | USER FACILITY |
| Date Received | 2018-10-22 |
| Date of Report | 2018-10-22 |
| Date of Event | 2018-09-24 |
| Date Mfgr Received | 2018-09-24 |
| Date Added to Maude | 2018-10-22 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | PERCUTANEOUS TRAY |
| Generic Name | ANGIOGRAPHY/ANGIOPLASTY KIT |
| Product Code | OEQ |
| Date Received | 2018-10-22 |
| Model Number | 89-5525 |
| Lot Number | 47941027 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2018-10-22 |