MAUDE Adverse Event Report: ETHICON INC. SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM); AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED

Model Number 411961

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 11/10/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).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.Additional information was requested, and the following was obtained: please clarify if the event mentioned was previously reported to ethicon? if so, provide the respective reference number(s).No event reported previously to j&j romania, as they seem to have confirmed by themselves that the product was compliant.Did the outer package show any signs of damaged when received? was the package properly sealed when received? as per pictures received there does not seem to be any issue, and the distributor did not complain about any kind of damage, only the missing ec rep on the outer box details.Please clarify, if is a local label missing from the packing? no, it's not a local label that is missing.The data is missing from the original packaging.As per pictures, the ec rep data is not visible on the outer packaging and labeling.In previous version carton (this data was visible on a side of the packaging).Please clarify quantity involved? a: 2 boxes of code: 411961, lot#: qdb3991.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.

Event Description

It was reported that at the compliance checks of the products received on (b)(6) 2020 in the warehouse, it was discovered that 2 boxes of absorbable hemostat, did not bear the ec rep details.No adverse patient consequences were reported.Additional information was requested.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 12/29/20.Investigation summary => three photos were received for analysis.A review of european medical device directive (mdd) and manufacturing specifications from san lorenzo confirmed that the product was manufactured according to specifications and the product meets the ce-mark requirements.Per the european medical device directive (mdd) requirements, the authorized representative information must appear on the product label or the outer packaging or the instructions for use.For surgicel fibrillar, the authorized representative is printed on the outer-package (the carton tray), the product label (the sterile barrier), and on the instructions for use.While the carton sleeve covers the authorized representative information and must be slid forward or back to reveal the information printed on the side of the carton tray, the carton tray and sleeve are two components of the outer-package and still meets the mdd requirements.Based the investigation, the complaint is not confirmed.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 1INX2IN(2.5CMX5.1CM)
• Type of Device: AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10981088
• MDR Text Key: 238971318
• Report Number: 2210968-2020-09802
• Device Sequence Number: 1
• Product Code: LMG
• UDI-Device Identifier: 10705031005198
• UDI-Public: 10705031005198
• Combination Product (y/n): N
• PMA/PMN Number: N12159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 11/11/2020

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 Expiration Date: 11/30/2022
• Device Model Number: 411961
• Device Catalogue Number: 411961
• Device Lot Number: QDB3991
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/11/2020
• Initial Date FDA Received: 12/09/2020
• Supplement Dates Manufacturer Received: 12/03/2020; 02/23/2021
• Supplement Dates FDA Received: 12/29/2020; 02/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1