MAUDE Adverse Event Report: ETHICON INC. VICRYL PLUS SUTURE 18"(45CM) 3-0 VIO; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number VCP772D

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/18/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.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.

Event Description

It was reported that a patient underwent unknown procedure on (b)(6) 2018 and suture was used.During the procedure, the staff found that the needle in the fourth slot seemed like 3/8 circle and wrong shape.The suture was not used on the patient.There were no adverse consequences to the patient.

Manufacturer Narrative

Product complaint # pc-(b)(4).Date sent to the fda: (b)(4) 2018.An empty opened foil, a paper lid, a winding former with eight parked needle/suture combinations of product were returned for analysis.During the visual inspection of needles, no incorrect component was observed.However, the needle of slot # 4 was noted that the curve of the needle is not smooth in comparison with the needle specification and is outside of curve tolerance.In addition, the suture was examined and no defects or damaged were found.The remaining needles were examined and no defects or damaged were found.The sutures were examined and no defects or damaged were found.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the sample received, an incorrect curvature was observed on the needle that at first seemed to be an incorrect component which corresponds to the reported complaint.

• Brand Name: VICRYL PLUS SUTURE 18"(45CM) 3-0 VIO
• 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.-SAN ANGELO; 3348 pulliam st; san angelo TX 76905 4403
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7769632
• MDR Text Key: 116660358
• Report Number: 2210968-2018-75048
• Device Sequence Number: 1
• Product Code: GAM
• UDI-Device Identifier: 10705031055476
• UDI-Public: 10705031055476
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K032420
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: VCP772D
• Device Lot Number: MA2770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1