MAUDE Adverse Event Report: ETHICON INC. ETHILON BLK 45CM 5/0 P-1 PRIME; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number W1611T

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/20/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.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.Did any piece of the needle fall inside of the patient? if so, was the needle piece removed and how? when did the needle pull off (while in the package / during dispensing / during preparation / during use)? batch number ljt840 is invalid.Please provide the correct batch number.

Event Description

It was reported that a patient underwent a plastic surgery procedure on (b)(6) 2018 and suture was used.When using the suture, the suture detached from the needle.No patient consequences were reported.Additional information has been requested.

Manufacturer Narrative

Product complaint # (b)(4).Additional information was requested and the following was obtained: 1.Did any piece of the needle fall inside of the patient? if so, was the needle piece removed and how? there's no piece fell inside patient.2.When did the needle pull off (while in the package / during dispensing / during preparation / during use)? the needle is pull off during the preparation.3.Batch number (b)(4) is invalid.Please provide the correct batch number - the batch number can't be provided at the moment despite the follow up.The customer discarded the product.

• Brand Name: ETHILON BLK 45CM 5/0 P-1 PRIME
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7336716
• MDR Text Key: 102329124
• Report Number: 2210968-2018-71415
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: W1611T
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2018
• 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