MAUDE Adverse Event Report: ETHICON INC. VCL RAP UD 27IN 4-0 S/A RB-1; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VR214
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.Additional information was requested, and the following was obtained: please clarify when the event occurred - when the returned product was observed, it was found that degradation has begun.A review of the batch manufacturing records was conducted, and no related non-conformances were identified.Investigation summary the product was returned to ethicon for evaluation.Four labeled winding formers with an undispensed suture and a detached needle each that pertain to product code vr214 were received for analysis.Additionally, a photo was provided, with the same condition as the received sample.During visual inspection of the samples, it was observed that the winding former contained a suture.However, the suture cannot be dispensed due to it has begun with the degradation process; per the sample condition, the functional test cannot be performed.In addition, the swage and attachment area were noted to be as expected.The barrel hole was examined under magnification and remnant suture was noted.The foil was visually inspected, and excessive wrinkles and holes in the cavity were observed.The reported event is confirmed.Due to the damages found on the packaging, a possible cause for this condition is due to improper handling during transit or storage.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.
Event or Problem Description
It was reported that patient underwent an unknown procedure on an unknown date, and suture was used.The suture was broken at the root of the needle.It was not a control release needle.There were no adverse consequences to the patient.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 8/16/2024.H6 component code: g07002 no device problem found additional information: d4 corrected information: h6 investigational codes, h3 investigation summaries - the product was returned to ethicon for evaluation.Two unopened samples that pertain to product code vr214 were received for analysis.Additionally, a photo was provided, with the same condition as the received sample.During visual inspection of the samples, the packets were opened.It was observed that the winding former contained a suture.However, the suture cannot be dispensed due to it has begun with the degradation process; per the sample condition, the functional test cannot be performed.The foil was visually inspected, and excessive wrinkles and holes in the cavity were observed.The reported event is confirmed.Due to the damages found on the packaging, a possible cause for this condition is due to improper handling during transit or storage.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.The product was returned to ethicon for evaluation.Four labeled winding formers with an undispensed suture and a detached needle each that pertain to product code vr214 were received for analysis.Additionally, a photo was provided, with the same condition as the received sample.During visual inspection of the samples, it was observed that the winding former contained a suture.However, the suture cannot be dispensed due to it has begun with the degradation process; per the sample condition, the functional test cannot be performed.In addition, the swage and attachment area were noted to be as expected.The barrel hole was examined under magnification and remnant suture was noted.The time of exposure of the suture to the environment could not be determined and the foils were not returned to determine the assignable cause.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.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.

• Brand Name: VCL RAP UD 27IN 4-0 S/A RB-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-GMBH; robert-koch strasse 1; p.o. box 1409; norderstedt ; GM
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 19618048
• Report Number: 2210968-2024-06650
• Device Sequence Number: 12503331
• Product Code: GAM
• UDI-Device Identifier: 10705031134607
• UDI-Public: (01)10705031134607(11)191112(17)250401(10)PMCCMKE0
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K033746
• 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

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 Expiration Date: 04/01/2025
• Device Catalogue Number: VR214
• Device Lot Number: PMCCMKE0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2024
• Supplement Date Received by Manufacturer: 07/19/2024
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown