MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC OTHER ACCESSORIES; ROD, COLOSTOMY

Model Number 022355

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

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

Event Date 04/01/2022

Event Type  malfunction  

Event Description

It was reported by retailer about seal incomplete.It was unknown if the device was used.The photographs were received from complainant depicting the issue.

Manufacturer Narrative

Device 2 of 2.(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).

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 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 1f04060 was manufactured on 29/june/2021, in handpack line, with a total of (b)(4) market units (mkus).The compliance engineer performed a batch record review on 18/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, systems applications and products (sap) material id 1709735 and manufacturing order (b)(4).The production process, in-process control, testing results and packaging of products was run according to the process instructions (pi31-016 ver.32.0 & pi29-018 ver.14.0) and recorded in br29-018 ver.10.0.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 18/sep/2023, compliance engineer ran a query in database in order to verify the complaints reported for the handpack manufacturing line for the malfunction code 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 part of product is trapped in packaging¿ and as result, no additional complaints were found.Historical nonconformance review: on 18/sep/2023, compliance engineer ran a query in database looking for any in process nonconformance / corrective and preventive actions (capa) (s) associated to the malfunction code 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 part of product is trapped in packaging¿ for the lot number 1f04060 and as result, no nonconformance / corrective and 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 pi29-018 ver.14.0, the following tests are performed in the manufacturing lines, in order to identify this failure mode in our manufacturing process: test method tm-002 ¿seal integrity ¿ 180 peel test¿ ¿ method 5: ¿ frequency: 5 samples per shift ¿ sample quantity: 5 units per head ¿ acceptance criteria: accept = 0 | reject = 1 defect rate analysis: there have only been 2 defective parts confirmed to date from a lot size of 6960 products.This represents a defect rate of only 0.03%, which is well within an appropriate acceptable quality level (aql) for this defect which should be 0.25% based on our (b)(4) ver.24.0.In addition, all of the in-process testing on this lot did not find a single defective pouch, 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: 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 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 part of product is trapped in packaging¿.No additional complaints were reported for lot affected related to the malfunction code 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 part of product is trapped in packaging¿.Based on this, no negative trend was identified.Based on preliminary investigation results, there is no objective evidence that other products from this lot are impacted, and the issue appears to be isolated.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.

• Brand Name: OTHER ACCESSORIES
• Type of Device: ROD, COLOSTOMY
• 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: 16032672
• MDR Text Key: 308367096
• Report Number: 9618003-2022-05417
• Device Sequence Number: 1
• Product Code: EZP
• 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: 11/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 022355
• Device Lot Number: 1F04060
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 09/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2021
• 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