MAUDE Adverse Event Report: ETHICON INC. SURGICEL ORIGINAL 2INX3IN(5.1CMX7.6CM); AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED

Model Number 1953

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 10/25/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).The following information was requested, but unavailable: how was the product purchased? is there an indication of how the product was distributed? is there any indication of the source? based on the packaging, is there any indication of which market the original genuine product may have come from? was the device used on a patient? if so, was there any patient consequence? photo investigation summary: visual analysis determined that a sealed box with product code 1953 was received for evaluation.The packaging was observed to be according to the process specifications and the product was manufactured by ethicon, the diversion product is confirmed, since the ethicon product was not distributed by an authorized affiliate.Investigation summary: the product was returned and were evaluated.It was observed that the carton was assembled in an incorrect manner, and the shading a corner of the packaging appeared incorrect.The foil pouch inside appearance seems shinier than the approved foil material inside appearance.In addition, it was noted time stamp was identical for all packages of the same line.The construction of device did not match that of surgicel but matched that of a competitor device.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Event related to mw # 2210968-2022-06656, mw # 2210968-2022-06686, mw # 2210968-2022-06688 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 Description

A suspected product inquiry of beijing ruimeidikang science trade co.,ltd., during an ipo investigation.China supply chain checked and there was no record of the absorbable hemostat products.Additional information was requested.

• Brand Name: SURGICEL ORIGINAL 2INX3IN(5.1CMX7.6CM)
• Type of Device: 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 00754 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15242656
• MDR Text Key: 305161003
• Report Number: 2210968-2022-06652
• Device Sequence Number: 1
• Product Code: LMG
• UDI-Device Identifier: 10705031003033
• UDI-Public: 10705031003033
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: N12159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/16/2022

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
• Device Operator: Health Professional
• Device Model Number: 1953
• Device Catalogue Number: 1953
• Device Lot Number: PPE4661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2022
• Initial Date Manufacturer Received: 08/08/2022
• Initial Date FDA Received: 08/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2019
• 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