MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC DUODERM; DRESSING,WOUND,OCCLUSIVE

Model Number 187644

Device Problems Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444); Packaging Problem (3007)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Device 1 of 5.Complainant city: (b)(6).Complainant country: mexico.Based on the available information, this event is deemed to be a reportable malfunction.Per clinical team, based on photos, seal not damaged was not guaranteed.Hence, this case is being submitted for the same.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.

Event Description

It was reported that the primary packaging was crushed.The customer did not wish to provide further information.The product was not used.The photographs depicting the issue were received from the complainant.

Event Description

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

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: there are photographs associated with this case and in these, the reported defect can be seen.No unused return sample was expected.Batch record revision results: lot 1m00624 was manufactured on 06/dec/2021, in bopack line, with a total of (b)(4) market units (mkus).The complaint investigator performed a batch record review on 03/oct/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 1704758 and manufacturing order (b)(4).The production process, in-process control, testing results and packaging of products was run according to the applicable process instruction (automated packaging bopack sterile and non-sterile products), 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 discrepancy related to this issue were found within the documentation.Historical complaints review: on 03/oct/2023, complaint investigator ran a query in database from 01/jan/2022 to 03/oct/2023 in order to verify the complaints reported for the lot number 1m00624 for the malfunction code ¿primary pack (sterile products) has incomplete or open seal / weld, or is torn, ripped or contains holes or exhibits external contamination (e.G.Water marks, stains), or dressing or loose material is trapped in packaging¿ and as result, no additional complaints were found.Historical nonconformance review: on 03/oct/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 ¿primary pack (sterile products) has incomplete or open seal / weld, or is torn, ripped or contains holes or exhibits external contamination (e.G.Water marks, stains), or dressing or loose material is trapped in packaging¿ for the lot number 1m00624 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 (automated packaging bopack sterile and non-sterile products), the following tests are performed in the manufacturing lines, in order to identify this failure mode in our manufacturing process: tm - 002 ¿package seal integrity nonconformities- method 7: frequency: first piece, each 30 minutes, at the beginning of the shift.Sample quantity: 5 samples.Specification: visual - nlt 2 per cavity / manual peel.Acceptance criteria: accept = 0 | reject = 1.Defect rate analysis: there have only been 5 defective parts confirmed to date from a lot size of 12,500 products.This represents a defect rate of only (b)(4) which is well within an appropriate acceptable quality level (aql) for primary pack (sterile products) has incomplete or open seal / weld, or is torn, ripped or contains holes or exhibits external contamination (e.G.Water marks, stains), or dressing or loose material is trapped in packaging 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 0.25.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: there are photographs associated with this case and in these, the reported defect can be seen and confirmed.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 ¿primary pack (sterile products) has incomplete or open seal / weld, or is torn, ripped or contains holes or exhibits external contamination (e.G.Water marks, stains), or dressing or loose material is trapped in packaging¿.No additional complaints were reported for lot affected related to the malfunction code ¿primary pack (sterile products) has incomplete or open seal / weld, or is torn, ripped or contains holes or exhibits external contamination (e.G.Water marks, stains), or dressing or loose material is trapped in packaging¿.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.

• Brand Name: DUODERM
• Type of Device: DRESSING,WOUND,OCCLUSIVE
• 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: 15484555
• MDR Text Key: 305881710
• Report Number: 9618003-2022-04949
• Device Sequence Number: 1
• Product Code: NAD
• UDI-Device Identifier: 00768455174751
• UDI-Public: 00768455174751
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 187644
• Device Lot Number: 1M00624
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 10/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2021
• 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