MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC L3W0750 - DUODERM; NOT APPLICABLE

Model Number 421644

Device Problem Difficult to Remove (1528)

Patient Problem Erythema (1840)

Event Type  malfunction  

Event Description

This emdr is for an additional unknown quantity of affected dressings and unknown number of babies.The issue was reported on tuesday, (b)(6) 2022, when an electronic mail (e-mail) was received from sales representative of advanced wound care (awc) / (negative pressure wound therapy (npwt) regarding a complaint from pharmacist at the hospital center of troyes about the dressing.It was reported by pharmacist that the dressing was very difficult to remove which caused redness on the babies' skin.The neonatology department used this product on the face to protect the skin when placing nasogastric tubes.It was placed under the tube, before placing a film dressing above the tube.The pharmacist also reported that the events encountered occur with all the dressings of this lot.The dressing was used for a short time due to a competitor's product being out of stock.The nurse explained that the dressing was applied to protect the healthy skin of newborn babies, then it was covered with a polyurethane film as part of the placement of nasogastric tubes.It was not identified as a misuse.This protocol was identical to that used with the competitor hydrocolloid dressing.The dressing was left in place for seven days.At the end of the seven days when the nurses wanted to remove the dressing it was impossible to remove it in accordance with the recommendations for use.All dressings are concerned but the number of dressings could not be obtained.No photograph is available at this time.

Manufacturer Narrative

Common device name - dressing, wound, occlusive complainant street address: (b)(6) hospitalier complainant city: (b)(6).Complainant postal code: (b)(6).Complainant country: (b)(6).Name of affiliation: (b)(6).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).

Manufacturer Narrative

Additional information - this emdr is being submitted to include the below: h6: investigation results under imdrf cause investigation code, imdrf investigation findings, imdrf cause conclusions.Photograph, video and/or physical sample evaluation: no photographs associated with this case were received and no unused return sample was expected.Batch record revision results: lot 1g03119 was manufactured on 28/jul/2021, in doyen b line, with a total of (b)(4) market units (mkus).The complaint investigator performed a batch record review on 25/sep/2023, to verify if all the applicable procedures were followed and no issues were found; all the components for assembly were correct per bill of materials (bom) and all the tooling information documented was also correct, system application product (sap) material id 1715224 and manufacturing order (b)(4).The production process, in-process control, testing results and packaging of products was run according to the process instruction (automatic packaging chevron sleeve doyen).Bulk dressing batch record revision: during the manufacturing process of affected lot 1g03119, was used bulk dressing lot 1g01862.This bulk lot was manufactured in elc#11 manufacturing line.No discrepancies related to the issue reported were found during the manufacturing process of this bulk lot.The production process, in-process control, testing results and packaging of products was run according to the process instruction (pi) and br31-141 (batch record for elc#11).Bulk mass batch record revision: during the manufacturing process of affected lot 1g03119, were used bulk mass lot 1f04939, 1g01170, 1g03408, 1g03407, 1g02232 and 1g02233.These bulk lots were manufactured in roping durahesive mix manufacturing line.No discrepancies related to the issue reported were found during the manufacturing process of these bulk lots.The production process, in-process control, testing results and packaging of products was run according to the process instruction (roping adhesive mass process instructions).Review of the batch records showed that all relevant tests required during the manufacturing process and final product release had been fulfilled and met the requirements.No discrepancy related to this issue were found within the documentation.Historical complaints review: on 25/sep/2023, complaint investigator ran a query in database from 01/jan/2022 to 25/sep/2023 in order to verify the complaints reported for the lot number 1g03119 for the malfunction code ¿adhesive dressing requires excessive force for removal from skin (i.E.Difficult to remove)¿ and as result, no additional complaints were found.Historical nonconformance review: on 25/sep/2023, complaint investigator ran a query in database looking for any in process nonconformance / corrective action / preventive actions (capa) (s) associated to the malfunction code ¿adhesive dressing requires excessive force for removal from skin (i.E.Difficult to remove)¿ for the lot number 1g03119 and as result, no nonconformance / corrective action / preventive actions (capa) (s) for this malfunction code were generated during the manufacturing process of the referenced lot.Current quality controls: based on the process instruction (pi), the following tests are performed in the manufacturing lines, in order to identify this failure mode in our manufacturing process: test methods (tm-011 ) ¿adhesive tack tests - method 2: frequency: once per shift or if settings changed.Sample quantity: 2 samples.Specification: nmt 1¿ travel.Acceptance criteria: accept = 0 | reject = 1.Defect rate analysis: there has only been 1 defective part confirmed to date from a lot size of 120,000 products.This represents a defect rate of only(b)(4) , which is well within an appropriate acceptable quality level (aql) for adhesive issues which should be (b)(4) based on our standard operating procedure (sop).In addition, all of the in-process testing on this lot did not find an adhesive issues, which confirms that the lot is unlikely to breach an acceptable quality level (aql) of 0.65.This issue certainly appears to be an isolated incident, but more importantly to date, it is well within our accepted acceptable quality level (aql) level for this type of failure mode or defect.Conclusions: no objective evidence was received such as a photo or sample, for this reason, we cannot conclude that the product does not meet specifications.The review of the batch record showed that all relevant tests required during the manufacturing process and final product release had been fulfilled and met the requirements.No nonconformity has been registered during the manufacturing process of the affected lot for the malfunction code ¿adhesive dressing requires excessive force for removal from skin (i.E.Difficult to remove)¿.No additional complaints were reported for lot affected related to the malfunction code ¿adhesive dressing requires excessive force for removal from skin (i.E.Difficult to remove)¿.Based on this, no negative trend was identified.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.Fda registration number: reporting site: 1049092.Manufacturing site: 9618003.

Event Description

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

• Brand Name: L3W0750 - DUODERM
• Type of Device: NOT APPLICABLE
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal 91000 ; DR 91000
• Manufacturer (Section G): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal 91000 ; DR 91000
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC ; 3365424679
• MDR Report Key: 14018977
• MDR Text Key: 288680794
• Report Number: 9618003-2022-00458
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 421644
• Device Lot Number: 1G03119
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/28/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1