MAUDE Adverse Event Report: ETHICON INC. SURGICEL FIBRILLAR 2INX4IN(5.1CMX10.2CM); AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED

Catalog Number	1962
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).H6.Component code: g07002 - device not returned attempts have been made to retrieve the device.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.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.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and absorbable hemostat was used.It was found that there had been filamentous foreign matter on the product before using on patient during surgery.Changed to another two to continue the surgery, the same problem happened.Changed to another one to complete the surgery.No adverse patient consequences were reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information was requested, and the following was obtained: where was the foreign material found? (inside the sterile barrier or outside of the sterile barrier?) it's fiber inside the sterile product.Is it possible that the foreign material fell into packaging upon opening of device? no.Was the product seal on the foil still intact when the package was opened? yes.A manufacturing record evaluation was performed for the finished device batch and no non-conformances were identified.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information was requested, and the following was obtained: our failure analysis lab received an additional product with reference to this complaint, the following product was received: - product code: 1962, lot tpe8201.- product code: 1962, lot uab1081.This complaint is for product code product code: 1962, lot tpe8201.1.Please clarify if the additional devices from 1962/uab1081 belong to this complaint? yes, the impacted product code is 1962 , lot number tpe8201 , involved quantity to be 1 and returned should be 1.The impacted product code 1962 , lot number should be uab1081 , involved quantity to be 2 and returned should be 2.And we updated related information in the a-11917855 on oct 11th.2.If not, please clarify if the additional received product belongs to a different complaint? if so, can you please provide the complaint number.Na 3.If the device was not reported before, please provide more details of device malfunction.Na.4.If the product doesn¿t belong to any complaint and was returned in error, please let us know so we can discard it or advise if the product is required to be returned.Na.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Corrected information: d 9.Device available for evaluation? additional information: d 9.Date device returned to manufacturer, d 9.Is device returned to manufacturer?, h 6.Component code, h 6.Type of investigation, h 6.Investigation findings, h 6.Investigation conclusions.H6 component code: g07002 - pending evaluation of returned device.The device upon which this medwatch is based has been received, however, the evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information was requested, and the following was obtained: the complaint was initially reported to have a quantity of three involved for product code 1962 and lot number tpe8201.Based on the latest additional information please clarify the following: 1.Did a quantity of 3 devices corresponding to product code 1962, lot number tpe8201 have foreign matter? yes.The foreign matter is the fiber, it would be the incomplete fibrillation, but customer thought they are foreign matters.2.Was there any alleged quality deficiency with product code 1962, lot number uab1081? no, just three products have incomplete fibrillation.3.If the answer to question two is yes, what quantity of devices from product code 1962, lot number uab1081 experienced an alleged quality deficiency.Na.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Corrected information: h 3.Device evaluated by manufacturer? additional information: h 6.Component code, h 6.Type of investigation, h 6.Investigation findings, h 6.Investigation conclusions.Investigation summary: the product was returned to ethicon for evaluation.One open sample with a surgicel fibrillar was returned for analysis.Product code 1962.Upon visual inspection of the sample, no foreign matter was noted.But it was found that a portion of the surgicel fibrillar was not fibrillated.Based on the information currently available, workmanship defect was identified during the investigation of the sample received.This product issue will be addressed through the ethicon quality system.A manufacturing record evaluation was performed for the finished device batch and no non-conformances were identified.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.

• Brand Name: SURGICEL FIBRILLAR 2INX4IN(5.1CMX10.2CM)
• Common Device Name: AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km 8.3; san lorenzo PR 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 20333301
• Report Number: 2210968-2024-10388
• Device Sequence Number: 12796058
• Product Code: LMG
• UDI-Device Identifier: 10705031003125
• UDI-Public: (01)10705031003125(17)260930(10)TPE8201
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: N12159
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 11/06/2024

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: 09/30/2026
• Device Catalogue Number: 1962
• Device Lot Number: TPE8201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2024
• Supplement Date Received by Manufacturer: 10/08/2024; 10/11/2024; 10/25/2024; 10/31/2024; 11/06/2024
• Initial Report FDA Received Date: 09/30/2024
• Supplement Report FDA Received Date: 10/10/2024; 10/22/2024; 10/25/2024; 11/01/2024; 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2023
• 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