MAUDE Adverse Event Report: ETHICON INC. PRONOVA SUTURE 30"(75CM) 7-0 BLU; SUTURE, NON ABSORBABLE, SYNTHETIC

Catalog Number	M3703
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).A manufacturing record evaluation was performed for the finished device number, and no non-conformance's were identified.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.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date in 2019 and suture was used.The suture was detached from the needle easily.It was not a control release needle.There were no adverse consequences to the patient.

• Brand Name: PRONOVA SUTURE 30"(75CM) 7-0 BLU
• Common Device Name: SUTURE, NON ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9168280
• Report Number: 2210968-2019-88474
• Device Sequence Number: 17054744
• Product Code: GAW
• UDI-Device Identifier: 10705031045125
• UDI-Public: 10705031045125
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K001625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/12/2019

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: 04/30/2023
• Device Catalogue Number: M3703
• Device Lot Number: MEQ299
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/12/2019
• Initial Report FDA Received Date: 10/08/2019
• Patient Sequence Number: 1