MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 96IN 1 S/A BP-1 LP; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	D8892
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
2 x boxes of the same code (d8892) blunt point 1 pds.It was reported that the pictures of the needles on the boxes (and packaging) show different needle pictures although both are blunt.Did the event occur during sterile processing? unknown, did the event occur during field inspection? unknown, did the event occur during internal service activities such as calibration? unknown, patient status/ outcome / consequences: no patient involvement, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown, is the patient part of a clinical study? unknown, (b)(4).Device property of hospital, device in possession of none, by checking this box i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst.True.
Additional Manufacturer Narrative
Product complaint # (b)(4).H6 component code: g07002 - device not returned.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.A photo upon which this medwatch is based has been received, however, the photo evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.1.Please confirm if the two boxes has the same lot number.2.Please provide picture of the second box with lot number.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 5/5/2025.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H6 component code: g07002 no device returned.H6 component code: c22 - photo analysis.Additional information: h6.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.H3 photo investigational summary: this is an analysis for a photo submitted to ethicon for evaluation.During the visual analysis, the following was observed: the photo shows two boxes of product code d8892 and one of the boxes appears to have different printed information; no labeling issues were found on the product in the box showing the lot number in the image.The picture is not clear to determine the fault as the second box does not have the lot number visible.The finished drawing one box was compared with the received image and all information was correct.As part of our quality process, the manufacturing records for this lot serial number were reviewed and manufacturing standards were met prior to the release of this lot.As part of ethicon's quality process, all devices are manufactured, inspected and released to approved specifications.Additional monitoring of complaint information for potential safety signals is conducted through complaint trends as part of post-market surveillance.

• Brand Name: PDSII VIO 96IN 1 S/A BP-1 LP
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 21055059
• Report Number: 2210968-2025-00005
• Device Sequence Number: 12796197
• Product Code: NEW
• UDI-Device Identifier: 10705031031456
• UDI-Public: (01)10705031031456(17)280630(10)THMBDR
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: N18331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: D8892
• Device Lot Number: THMBDR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2024
• Supplement Date Received by Manufacturer: 04/08/2025
• Initial Report FDA Received Date: 01/02/2025
• Supplement Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/06/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown