MAUDE Adverse Event Report: ETHICON INC. PROLENE BLU 18IN 4-0 S/A PS-3 PRM MP; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	EH7764H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluation summary: a box with thirty-four unopened samples of product code eh7764h, lot meh434 were received for analysis.The complaint sample was not returned for analysis.During the visual inspection of thirteen unopened samples, no defects were observed on the packets.The samples were opened, and the swage and attachment area were noted to be as expected.The sutures were examined along of strand and no defects or damaged were noted.A functional test was performed on the samples and the tensile force 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 suture was observed, and the tested sample meet the finished goods requirements.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.The suture broke during use.There were no adverse consequences to the patient.

• Brand Name: PROLENE BLU 18IN 4-0 S/A PS-3 PRM MP
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8458149
• Report Number: 2210968-2019-79750
• Device Sequence Number: 10870014
• Product Code: GAW
• UDI-Device Identifier: 10705031097964
• UDI-Public: 10705031097964
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K133356
• 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): 03/04/2019

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: EH7764H
• Device Lot Number: MEH434
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/04/2019
• Initial Report FDA Received Date: 03/27/2019
• Patient Sequence Number: 1