MAUDE Adverse Event Report: ETHICON INC. MONOCRYL UNDYED 1.0M 45CM W/ND; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number W3203

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

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

Event Description

It was reported that a patient underwent an unknown procedure on unknown date and suture was used.The thread was breaking off the needle.There were no patient consequences reported.

Manufacturer Narrative

Product complaint # pc-(b)(4).Representative samples were returned for evaluation.During the visual inspection of the samples no defects were found on the package.The sample was opened and the swage and attachment area of the needle were as expected.The suture was dispensed without problems and examined along of the strand and no defects or damages were observed.The sample was tested by needle pull and meet the finished goods requirements.Per the conditions of the samples received, no attachment defects were found and the tested samples met the finished goods requirements.

• Brand Name: MONOCRYL UNDYED 1.0M 45CM W/ND
• Type of Device: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• Manufacturer (Section G): ETHICON INC.-UK; simpson parkway; kirkton campus; livingston ; UK
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville 08876-0151 ; 9082182792
• MDR Report Key: 7225460
• MDR Text Key: 98854217
• Report Number: 2210968-2018-70502
• Device Sequence Number: 1
• Product Code: GAN
• Combination Product (y/n): N
• PMA/PMN Number: K964072
• 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: 01/10/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: W3203
• Device Lot Number: LB7BJRN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/10/2018
• Initial Date FDA Received: 01/29/2018
• Supplement Dates Manufacturer Received: 02/08/2018
• Supplement Dates FDA Received: 02/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2017
• 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