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

Catalog Number	Y835G
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A photo of the device has been received however the evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.Attempts are being 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.
Event or Problem Description
It was reported that the patient underwent an unknown procedure on an unknown date and suture was used.The device package had a fly in it.It is unknown what was used to complete the procedure.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
(b)(4).There was no sample received for analysis.Only pictures of the sample were received for analysis.Upon visual inspection of the picture, a foreign matter at the outer box could be observed.However no conclusion could be reach as the sample was not returned for analysis.A manufacturing record evaluation was performed for the finished device mm5274 number, and no non-conformances were identified.

• Brand Name: MONOCRYL SUTURE 18"(45CM) 4-0 UND
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8620753
• Report Number: 2210968-2019-81483
• Device Sequence Number: 13996454
• Product Code: GAN
• UDI-Device Identifier: 10705031059702
• UDI-Public: 10705031059702
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K964072
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: Y835G
• Device Lot Number: MM5274
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/24/2019
• Supplement Date Received by Manufacturer: 05/27/2019
• Initial Report FDA Received Date: 05/17/2019
• Supplement Report FDA Received Date: 06/13/2019
• Patient Sequence Number: 1