MAUDE Adverse Event Report: CONVATEC LTD SECUREMENTS; TAPE AND BANDAGE, ADHESIVE

Model Number 685M

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Initial reporter occupation: product specialist.Based on the available information, this event is deemed to be a reportable malfunction.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.(b)(4).

Event Description

It was reported there was foreign body found in the package.A photograph depicting the reported complaint issue was provided by the complainant.

Manufacturer Narrative

Correction (g1) - contact office address: dr.(b)(6).Uno drain fix 685m (20/160) ster int in question was manufactured under sap material id: 1301278 and manufacturing lot#: 8f04478.The securement was produced, visually checked under subassembly lots: 8f00918, 8d05163 on machine c080 and then packed in peelpacks (pouch) under lot: 8f04478 on june 2018 on center c2 on machine p013, with total lot amount 3 865 pce.Lot#: 8f04478 was sterilized under lot: uk33s12136122-3-1and released based on the review of results of sterilization provided by sterilization company steris.All the results were within specification and products were released in compliance with sop-000801.The production process, in-process control, testing result, packaging of products run according to the process instruction pi41-017 for subassembly process drainfix.Visual inspection of securement products acc.To tm-296sk was performed by quality assistant on beginning of order, on beginning of every shift and after every hour.Packaging was done on p013 according to the process instruction pi41-013 ver.3 for packing of sterile securements products.During packing process following tests are performed: burst test to evaluate strength of the weld, water leakage test for detection of holes in primary pack, peel test to check correct opening of the seal and 100% visual inspection for detection of any defects on packing.Based on the available record, all tests were performed and all results were within specification.Review of the dhr showed that all relevant tests required during the manufacturing process, packaging process and final product release had been fulfilled and met the requirements.No nonconformity has been registered during the manufacturing process of the mentioned lots.Photo of affected product has been received and visually evaluated.There was visible foreign material inside of peelpack.Foreign material was observed to be a piece of the release liner.Issue was discussed with quality and operators.The probable reason of release liner found inside of peelpack could be a human mistake, inattention of operator during packaging process when operators place and visually check every product.The root cause of this issue could be mentioned cause ¿ human mistake, inattention of operators.No other similar complaint was received on the lot.Based on the investigation results the issue is considered to be isolated.Should additional information become available, a follow-up report will be submitted.Fda registration number: reporting site: 1049092.Manufacturing site: 3005778470.

Event Description

To date no additional patient or event details have been received.

• Brand Name: SECUREMENTS
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): CONVATEC LTD; first avenue; deeside industrial park; deeside, flintshire CH5 2 NU; UK CH5 2NU
• MDR Report Key: 8846438
• MDR Text Key: 183959459
• Report Number: 3005778470-2019-00049
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/01/2021
• Device Model Number: 685M
• Device Lot Number: 8F04478
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 07/18/2019
• Initial Date FDA Received: 07/31/2019
• Supplement Dates Manufacturer Received: 07/18/2019
• Supplement Dates FDA Received: 03/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1