MAUDE Adverse Event Report: ETHICON INC. MONOCRYL SUTURE 18"(45CM) 4-0 UND; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number Y496G

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.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.Additional information was requested and the following was obtained: was the needle retrieved from the patient? yes.If yes, was it removed during same procedure? yes.Additional delay in procedural time/procedural alteration/change in post-op patient care/ additional tissue dissection or damage/other issues? explain in details.Is the needle retained in the patient? no.If yes, results of x-rays location (tissue structure) and size of retained needle.Any other adverse patient consequences? if yes, explain and indicate what medical/surgical intervention was provided.No.Any plans in place to remove the needle from the patient at a later date? no.How was case completed? removed needle and resumed case.

Event Description

It was reported that a patient underwent a breast lumpectomy on an unknown date and suture was used.During the procedure, the suture detached from needle.The needle fell into the patient.The needle was located with c-arm during the procedure and removed.There were no adverse patient consequences.Additional information had been requested and was obtained.No additional information is available.

• Brand Name: MONOCRYL SUTURE 18"(45CM) 4-0 UND
• Type of Device: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.; avenida de las torres 7125; col salvacar; ciudad juarez ; MX
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7655485
• MDR Text Key: 113049930
• Report Number: 2210968-2018-73987
• Device Sequence Number: 1
• Product Code: GAN
• UDI-Device Identifier: 10705031059375
• UDI-Public: 10705031059375
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964072
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: Y496G
• Device Lot Number: MCK126
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1