MAUDE Adverse Event Report: ETHICON INC. MONOCRYL UD 18IN USP5-0::S/A PS-2 PRIME MP; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number MPY495H

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/02/2018

Event Type  malfunction  

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.Additional information was requested and the following was obtained: please further clarify the event description, ¿needle dissolved from the suture.¿ a.Did the needle pull off from the suture? if so, when did the needle pull off (while in the package / during dispensing / during preparation / during use)? not in the package but unknown if it was in use.Was the needle found detached from the suture in the package? no.Was the suture degraded? no.

Event Description

It was reported that a patient underwent an unknown surgical procedure on (b)(6) 2018 and suture was used.During the procedure, the needle dissolved from the suture.There were no adverse patient consequences.Additional information had been requested.

Manufacturer Narrative

Pc-(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.Additional h3 summary: representative samples were returned for analysis.The issue sample was not received for evaluation.During the visual inspection of sample, no defects were found on the package.The sample was opened and the swage and attachment area were as expected.The suture was dispensed without problems and examined along of the strand and no defects were observed.The sample was tested by needle pull and met the finished goods requirements.Per the conditions of the representative sample, no attachment defects were found and the tested sample met the finished goods requirements.

• Brand Name: MONOCRYL UD 18IN USP5-0::S/A PS-2 PRIME MP
• 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; 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: 7303642
• MDR Text Key: 101271493
• Report Number: 2210968-2018-71095
• Device Sequence Number: 1
• Product Code: GAN
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K964072
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/14/2018

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: 02/28/2022
• Device Catalogue Number: MPY495H
• Device Lot Number: LCZ603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/14/2018
• Initial Date FDA Received: 02/28/2018
• Supplement Dates Manufacturer Received: 03/09/2018
• Supplement Dates FDA Received: 04/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2017
• 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