MAUDE Adverse Event Report: ETHICON INC. PRNVA BLU 36IN 5-0 D/A RB-1; SUTURE, NON ABSORBABLE, SYNTHETIC

Model Number	3556H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/31/2020
Type of Reportable Event	Malfunction
Additional 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.
Event or Problem Description
It was reported that the patient underwent an unknown cardiovascular procedure on (b)(6) 2020 and suture was used.The suture was broken during continuous suturing.Further details are not provided.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 04/23/2020.Corrected information: d3,g1,g2.Additional information: d4,h4.A manufacturing record evaluation was performed for the finished device lot, and no non-conformities were identified.

• Brand Name: PRNVA BLU 36IN 5-0 D/A RB-1
• 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: 9765762
• Report Number: 2210968-2020-01588
• Device Sequence Number: 2650547
• Product Code: GAW
• UDI-Device Identifier: 10705031004498
• UDI-Public: 10705031004498
• 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,Followup
• Report Date (Section B): 02/03/2020

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: 03/31/2024
• Device Model Number: 3556H
• Device Catalogue Number: 3556H
• Device Lot Number: PDR589
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/03/2020
• Supplement Date Received by Manufacturer: 04/03/2020
• Initial Report FDA Received Date: 02/27/2020
• Supplement Report FDA Received Date: 04/23/2020
• Patient Sequence Number: 1