MAUDE Adverse Event Report: ETHICON INC. GUT CHR UD 36IN 3-0 S/A FSL; SUTURE, ABSORBABLE, NATURAL

Catalog Number	932H
Medical Device Problem Code	Expiration Date Error (2528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.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.Please confirm lot #.Are you able to return product for evaluation? if so, please provide your address and we can send a return mailer kit.If not, can you please provide photos of the label with the missing expiration dates?.
Event or Problem Description
It was reported that during a routine check of materials, the box of suture was found to not have an expiration date on it.There was no patient involvement.
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).Date sent to the fda: (b)(4) 2018.The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.If the device or further details are received at a later date a supplemental medwatch will be sent.
Additional Manufacturer Narrative
Product complaint #: (b)(4).The batch lot number bcp572 is invalid for product code 932h.Therefore, the device history records could not be reviewed.If further details are received at a later date a supplemental medwatch will be sent.

• Brand Name: GUT CHR UD 36IN 3-0 S/A FSL
• Common Device Name: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7822598
• Report Number: 2210968-2018-75465
• Device Sequence Number: 19225961
• Product Code: GAL
• UDI-Device Identifier: 10705031022799
• UDI-Public: 10705031022799
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/31/2018

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: 01/31/2014
• Device Catalogue Number: 932H
• Device Lot Number: BCP572
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/31/2018
• Supplement Date Received by Manufacturer: 08/16/2018; 09/11/2018
• Initial Report FDA Received Date: 08/28/2018
• Supplement Report FDA Received Date: 09/11/2018; 09/28/2018
• Patient Sequence Number: 1