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

Catalog Number	3556H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 a tricuspid valvuloplasty on (b)(6) 2019 and suture was used.During the procedure, one needle of the double-armed suture was detached from the suture during continuous suturing on the valve.The dropped needle was found in the thoracic cavity.After that, the other side of the needle was detached from the suture during suturing.The needle was removed by visual inspection during the procedure.There were no adverse consequences to the patient.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 05/10/2019.A manufacturing record evaluation was performed for the finished device lch705, and no non-conformances were identified.
Additional Manufacturer Narrative
(b)(4).Ten unopened samples were returned for analysis.During the visual inspection of ten unopened samples, no defects were found on the packages.The samples were opened, and the swage and attachment area were as expected; also, the tip and body of the needles were examined no defects or needle breakage were observed.The sutures were dispensed without problems and examined along of the strand and no defect were observed.Also, the samples were tested by resistance test to needle and the needles met the 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 representative samples, no performance breakage needle were found on the sample.

• 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 0151
• MDR Report Key: 8523337
• Report Number: 2210968-2019-80450
• Device Sequence Number: 14122190
• 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,Followup
• Report Date (Section B): 03/22/2019

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: 02/28/2022
• Device Catalogue Number: 3556H
• Device Lot Number: LCH705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2019
• Initial Date Received by Manufacturer: 03/22/2019
• Supplement Date Received by Manufacturer: 05/01/2019; 05/24/2019
• Initial Report FDA Received Date: 04/17/2019
• Supplement Report FDA Received Date: 05/10/2019; 05/28/2019
• Patient Sequence Number: 1