MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC GRANUFLEX; NOT APPLICABLE

Model Number 187951

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  

Event Description

As per the photo received by the company representative from the end user, it appeared that the dressing was trapped in package seal.The product was not used on patient.A photograph depicting the issue was received from the complainant.

Manufacturer Narrative

Complainant street address: (b)(6).Name of affiliation : (b)(6).Please note that this case is being reported for possible product trapped in seal based on the attached photo with the complaint depicting one product.A follow up was done to confirm the issue but the complainant was not available for reply.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.Fda registration number reporting site: (b)(4).Manufacturing site: (b)(4).

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 h10: investigation summary.Batch record review: the lot 1m01305 was manufactured on 12 december 2021 doyen b manufacturing line, with a total of 6,300 market units.Complaint investigator 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 material 1000902 and manufacturing order 1610810.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: during the inspection process in doyen b line, on february 22nd of 2022, the quality inspector of the shift a, detected two (02) units with dressing trapped in the seal.The affected product belongs to the order 1610829, sap (system application product) code 1103434 and lot 2b02574.As per work instruction (package seal integrity nonconformities), product trapped in seal is not acceptable.The purpose of this root cause investigation is to identify the causes for the ncr (non-conformance report) generated at doyen b line due to trapped in the seal identified during the routine quality inspections performed on february 22nd of 2022 as well as the corresponding corrective and preventive actions required to prevent issue re occurrence.As a result of the investigation, in which the multidisciplinary team performed a 5why exercise to identify the root causes related with this defect, it was identified the following: root cause(s): pin stopper and guides mechanicals wears solutions: 1- corrective maintenance of the actual guides and pins stopper.2- include the review of those components in the preventive maintenance for doyen b 3- install or activate on the machine a system to catch trapped dressing on the seal and its corresponding validation for doyen b 4- retraining personnel of the doyen b 5- awareness personnel of doyen a and bodolay related to this issue 6- include the review of those components in the preventive maintenance of doyen a and bodolay line.A capa (corrective and preventive actions) plan will be generated to track the implementation of these actions and measure the effectiveness in the product and the process.The investigation associated with related event was approved and complete.No additional action was required, and this complaint will be closed.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: (b)(4).Manufacturing site: (b)(4).

• Brand Name: GRANUFLEX
• 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: 15536357
• MDR Text Key: 306616059
• Report Number: 9618003-2022-05112
• 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: Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 187951
• Device Lot Number: 1M01305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 11/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2021
• 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