MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC NATURA; PROTECTOR, OSTOMY

Model Number 125265

Device Problems Fluid/Blood Leak (1250); Material Separation (1562); Activation, Positioning or Separation Problem (2906); Positioning Problem (3009); Sharp Edges (4013); Separation Problem (4043)

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

Event Type  malfunction  

Manufacturer Narrative

Device 3 of 4.(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.

Event Description

The customer stated that she has used four appliances out of ten so far and found that the skirt around the flange ring was sharp and lifted off the skin barrier.She stated that it lifted off after four days and then, changed it to three in one night and afterwards, experienced leakage as well.The customer had a leakage from under the flange ring so she had put her hand there and found the area was sharp.The photographs were received from the complainant depicting the issue.

Manufacturer Narrative

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 2a02421 was manufactured on 1/14/2022, in mlk-6 line, with a total of (b)(4) market units (mkus).The compliance engineer performed a batch record review on 27/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 1002436 and manufacturing order (b)(4).The production process, in-process control, testing results and packaging of products was run according to the process instruction and recorded in mr21-093 (39.0).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 27/sep/2023, compliance engineer ran a query in database in order to verify the complaints reported for the 2a02421 lot for the malfunction code ¿skin barrier in contact with skin is too rough or sharp, sharp edges at stoma may occur¿ and as result, no additional type 2 complaints were identified during this search as per work instruction.Historical nonconformance review: on 27/sep/2023, compliance engineer ran a query in database looking for any in process nonconformance / corrective action / preventive actions (capa (s) associated to the malfunction code ¿skin barrier in contact with skin is too rough or sharp, sharp edges at stoma may occur¿ for the lot number 2a02421 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, the following tests are performed in the manufacturing lines, in order to identify this failure mode in our manufacturing process: test methods (tm-001 method 13) ¿visual inspection¿: frequency: 32 per turn (4 per hour).Sample quantity: 5 samples per head.Acceptance criteria: accept = 0 | reject = 1.Defect rate analysis: there have only been 4 defective parts confirmed to date from a lot size of (b)(4) products.This represents a defect rate of only (b)(4)%, which is well within an appropriate acceptable quality level (aql for this defect which should be (b)(4)% based on our standard operating procedure (sop) quality inspection plan¿.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 (b)(4).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 for lot 2a02421 showed that all relevant tests required during the manufacturing process and final product release had been fulfilled and met the requirements, all applicable manufacturing and quality processes were followed, and no discrepancies or deviations were recorded.No changes to the end-to-end manufacturing process or components used during assembly of the batch were made.No nonconformity has been registered during the manufacturing process of the affected lot for the malfunction code ¿skin barrier in contact with skin is too rough or sharp, sharp edges at stoma may occur¿.No additional complaints were reported for lot affected related to the malfunction code ¿skin barrier in contact with skin is too rough or sharp, sharp edges at stoma may occur¿.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.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: NATURA
• Type of Device: PROTECTOR, OSTOMY
• 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: 15400862
• MDR Text Key: 305520191
• Report Number: 9618003-2022-04945
• Device Sequence Number: 1
• Product Code: EXE
• UDI-Device Identifier: 00768455125449
• UDI-Public: 00768455125449
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 125265
• Device Lot Number: 2A02421
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 09/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2022
• 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
• Patient Sex: Female