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	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Event or Problem Description
It was reported that a patient underwent a cardiovascular procedure on (b)(6) 2019 and suture was used.During continuous suturing, the suture was detached from the needle.The needle was not control release needle.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 01/24/2020.Additional information: h4, h6.A manufacturing record evaluation was performed for the finished device number, and no non-conformities were identified.Additional h3 device evaluation summary: it was received for analysis (b)(4) unopened samples of product code 3556h, lot paj147.The complaint sample was not returned for analysis.During the visual inspection of thirteen samples, no defects were found on the packages.The samples were opened, and the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along of the strands and no defects were observed.A functional test was performed and the pull force were above the minimum requirements.The manufacturing records were reviewed, and the manufacturing/ packaging criteria were met prior to the release of this batch.Per the condition of the samples, no performance pull off suture needle was found, and the tested samples met the finished goods requirements.Representative samples returned to support investigation of device issues captured in reports 2210968-2019-91212, 2210968-2019-91213 and 2210968-2019-91214.Analysis results have been included in follow up reports for each.

• 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: 9508864
• Report Number: 2210968-2019-91214
• Device Sequence Number: 19506907
• Product Code: GAW
• UDI-Device Identifier: 10705031004498
• UDI-Public: 10705031004498
• Combination Product (Y/N): N
• 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): 12/03/2019

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: No Information
• Device Expiration Date: 12/31/2023
• Device Model Number: 3556H
• Device Catalogue Number: 3556H
• Device Lot Number: PAJ147
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/03/2019
• Supplement Date Received by Manufacturer: 01/08/2020
• Initial Report FDA Received Date: 12/22/2019
• Supplement Report FDA Received Date: 01/24/2020
• Patient Sequence Number: 1