MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC L3W0750 - DUODERM; DRESSING,WOUND,OCCLUSIVE

Model Number 187662

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

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

Event Type  malfunction  

Event Description

It was reported that there was seal on dressing reported during inspection.The product was not used.The photographs depicting the issue were received from the complainant.

Manufacturer Narrative

Device 2 of 4.Reporter 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 h10: investigation summary batch record review: the lot 1f03164 was manufactured on 23 june 2021 uhlmann#2 manufacturing line, with a total of(b)(4) market units.Complaint performed a batch record review on 30 october 2022, 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.Sap (system application product) material 1704763 and manufacturing order (b)(4).The batch record review supports that there were no discrepancies related to the issue reported.Returned sample evaluation: photo related to the reported problem is available for evaluation.Conclusion summary of the related event: the scope of this investigation covers the failure mode related to the malfunction code primary pack has incomplete or open seal / weld, or is torn, ripped or contains holes or exhibits external contamination, or dressing or loose material is trapped in packaging for doyen b and uhlmann #2 line, located at awc dominican republic facility.Where all products with control gel formula cgf and extra thin dressing are impacted.The risk level is classified as moderate based on the risk evaluation performed as part of the scope.The po rate of 1 (remote) was determined, which means that is highly unlikely that the harm will occur, which correspond to the reported complaints, as no harm to the end user happened.Based on the severity of the failure mode, categorized as critical on the event, a stop shipment was initiated for the impacted lots.In order to determine the possible causes of the malfunction code primary pack has incomplete or open seal / weld, or is torn, ripped or contains holes or exhibits external contamination, or dressing or loose material is trapped in packaging for doyen b and uhlmann #2 line, a brainstorming tool was used to determine all the possible causes to finally summarize them in a cause & effect diagram to regroup the finding according to six (6) m¿s (materials, process/method, measurement, manpower, machinery/equipment and environment) and discard or retain the potential causes.Based on the investigation findings, the following root causes were found per line and failure mode reported: doyen b caught in seal: -method, dressing not into infeed conveyor pitch -method, manual setting of indexation process during changeover -method, tensor of material positioning -machine, incorrect dressing tooling on machine uhlmann #2, caught in seal: - method, lack of visual help for manual dressing placement: - machine, suction cup worn out from pick and place: a capa (corrective and preventive actions) plan will be generated to track the implementation of this actions and measure the effectiveness in the product and the process.This issue will be monitored through the post market product monitoring review process, standard operating procedure (sop).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: 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: 15101535
• MDR Text Key: 296861331
• Report Number: 9618003-2022-04233
• Device Sequence Number: 1
• Product Code: NAD
• UDI-Device Identifier: 00768455174928
• UDI-Public: 00768455174928
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 187662
• Device Lot Number: 1F03164
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 11/01/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/23/2021
• 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