MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2018-10-25 for DUODERM/GRANUFLEX/DUOACTIVE - MOISTURE RETENTIVE DUODERM CGF DRESSING 187987 manufactured by Convatec Ltd.
[126371086]
Common device name: dressing, wound, hydrogel without drug and/or biologic. (b)(6). Based on the available information, this event is deemed to be a reportable malfunction. A batch record review indicates no discrepancies. Machine logs have been checked and no discrepancies were found. Preventive maintenance (pm) logs have been checked and all pm's were completed. Duoderm hydroactive gel (b)(4) lot number 8a02998, was manufactured in january 2018. Lot number 8a02998 was sterilized. All results were within specification and the products were released per specification. The production process, in process testing and packaging of products were run per specification for machine gel filler. Visual inspection was performed per specifications. Visual inspection was completed at the beginning of the order and every hour thereafter until the order was completed. No nonconformity was registered during the manufacturing of lot 8a02998. This is the only complaint for this issue raised against this manufacturing lot. Photographs were received for this complaint and were evaluated. Though photographs confirm that this is a convatec product and confirm the batch number. The photograph also shows the white cap ring is missing from the affected tube. A non- conformance was raised in (b)(6) 2018 for the same issue but with a different manufacturing lot. The root cause was found to be that there was a cap ring missing on the affected tube which is the same issue as the affected tube in this complaint. This was a supplier issue. A correction action was completed with the tube supplier in (b)(6) 2018 to ensure that this issue would not reoccur with their manufacturing process. As part of other corrections, training was also completed with all relevant operators in (b)(6) and (b)(6) 2018 to ensure that the cap ring was present when they visually inspect the tubes as they come off the filling line. This included a one-point lesson as well as the process instructions are being updated. All operators will be informed of the complaint issue. This issue will be monitored through the post market product monitoring review process. To date no additional information has been received. Should additional information become available, a follow-up report will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[126371087]
Complainant reported that? The cap was opened when he started to use.? It was further reported that the seal was not intact. The product was not used. Photos depicting the reported complaint issue were provided by the complainant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000317571-2018-00095 |
| MDR Report Key | 8006360 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2018-10-25 |
| Date Mfgr Received | 2018-10-02 |
| Date Added to Maude | 2018-10-25 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. JEANETTE JOHNSON |
| Manufacturer Street | 7900 TRIAD CENTER DRIVE SUITE 400 |
| Manufacturer City | GREENSBORO NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal | 27409 |
| Manufacturer G1 | CONVATEC LTD |
| Manufacturer Street | FIRST AVENUE DEESIDE INDUSTRIAL PARK |
| Manufacturer City | DEESIDE, FLINTSHIRE CH5 2NU |
| Manufacturer Country | UK |
| Manufacturer Postal Code | CH5 2NU |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DUODERM/GRANUFLEX/DUOACTIVE - MOISTURE RETENTIVE DUODERM CGF DRESSING |
| Product Code | NAE |
| Date Received | 2018-10-25 |
| Model Number | 187987 |
| Lot Number | 8A02998 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONVATEC LTD |
| Manufacturer Address | FIRST AVENUE DEESIDE INDUSTRIAL PARK DEESIDE, FLINTSHIRE CH5 2NU UK CH5 2NU |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-25 |