MAUDE Adverse Event Report: ETHICON INC. GUT PL FAG UD 18IN 5-0 S/A PC-1 PRM MP; SUTURE, ABSORBABLE, NATURAL

Catalog Number 1915G

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Type  malfunction  

Manufacturer Narrative

Product complaint #
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> (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.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.Photo analysis investigation summary: this is an analysis for a photo submitted to ethicon for evaluation.During the visual analysis, the following was observed: the photo shows an apparently closed aluminum package.The image is not clear to determine the failure mode or the reported condition.Based on the photo review, the event describe is not confirmed, however no conclusion or root cause could be determined.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.Because the instrument was not returned our evaluation is limited.We value the opportunity to fully analyze the instrument upon its return.As part of ethicon quality process all devices are manufactured, inspected, and released to approved specifications.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.Were x-rays taken to locate the needle piece(s)? - what measures were taken to retrieve the needle? - was there any additional tissue damage as a result of searching for the needle? - does a piece of the needle remain in the patient¿s tissue? if yes, ¿ is there any plan in place to remove the needle in the future? ¿ if yes, please provide the scheduled date.¿ what tissue structure the needle was located? ¿ what is the surgeon's opinion of consequences to the patient? - please provide the lot number: - please provide the source or name of person providing answers to follow-up questions:.

Event Description

It was reported that a patient underwent an unknown cardiovascular procedure on an unknown date and suture was used.During the procedure, ¿while attempting to close a skin incision with the above suture, the suture needle broke away from the suture and was possibly left inside the skin.While we wait for confirmatory scans as to the location of the needle, we are inquiring if this patient can have an mri.We are unsure if the suture needle is safe for mri.¿ the device is not available for return.No adverse patient consequences were reported.Additional information was requested.

Manufacturer Narrative

Product complaint # (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: h6, g1, d4 additional information was requested and the following was obtained: i think there is a misunderstanding.I wasn't filing a complaint.All i want to know is how much metal in grams is in the suture needle.Is there someone that could assist me with this information.The lot is: slmake.

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.A review of the batch manufacturing records was conducted, and no related non-conformance's were identified.

• Brand Name: GUT PL FAG UD 18IN 5-0 S/A PC-1 PRM MP
• Type of Device: SUTURE, ABSORBABLE, NATURAL
• 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: 18547957
• MDR Text Key: 333349970
• Report Number: 2210968-2024-00545
• Device Sequence Number: 1
• Product Code: GAL
• UDI-Device Identifier: 10705031002913
• UDI-Public: 10705031002913
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1915G
• Device Lot Number: SLMAKE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1