MAUDE Adverse Event Report: ETHICON INC. PRNVA BLU 36IN 4-0 D/A RB-1; SUTURE, NON ABSORBABLE, SYNTHETIC

Catalog Number	3557H
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
This is a follow-up to previously submitted events.Asr exemption: e1999004.Form code:(b)(4).Suture breakage malfunction events: 0.Suture breakage devices returned: 0.Manufacturing deficiency: 0.Needle breakage malfunction events: 0.Needle breakage devices returned: 0.Manufacturing deficiency: 0.Needle pull off malfunction events: 2.Needle pull off devices returned: 14.Manufacturing deficiency: 0.All devices labeled for single use; 0 devices reprocessed and re-used 0 remedial action a manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Complaint information will be included in complaint trending that is reviewed on a regular basis to determine if further action is necessary.
Event or Problem Description
This report summarizes 2 malfunction events, including 0 initial events.It summarizes follow up malfunction events, including 0 suture breakage, 0 needle breakage and 2 needle pull-off that occurred intraoperatively.

• Brand Name: PRNVA BLU 36IN 4-0 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 0151
• MDR Report Key: 8847631
• Report Number: 2210968-2019-84943
• Device Sequence Number: 2267718
• Product Code: GAW
• UDI-Device Identifier: 10705031004504
• UDI-Public: 10705031004504
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K001625
• Number of Events Summarized: 2
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/31/2019

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: 07/31/2023
• Device Catalogue Number: 3557H
• Device Lot Number: MJJ968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/31/2019
• Initial Report FDA Received Date: 07/31/2019
• Patient Sequence Number: 1