MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 18IN 7-0 D/A BV175-8 EP; SUTURE, NONABSORBABLE, SYNTHETIC

Model Number	EP8746H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) attempts are being 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.Additional information was requested and the following was obtained: no additional info provided, no patient consequence mentioned what was the name of the procedure? what was being done when the needle pulled-off (in the package/ removal from package / during passage through tissue)? were x-rays taken to locate the needle? was the needle piece removed from the patient during the same procedure? what is the condition of the patient? how many of the total quantity were actually involved for reported issue? note: events reported via mw# 2210968-2020-00840, 2210968-2020-00841, 2210968-2020-00842.
Event or Problem Description
It was reported that the patient underwent an unknown procedure on an unknown date and suture was used.The needle detached.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 02/26/2020.Corrected information: d4 lot number to unknown.Additional information: d10, h6.Additional information: d4, h4 - the actual device batch number associated with this event is not known.The international affiliate reports the following possible batch numbers: batch mmq077 mfg date: 11/27/2018, exp date: 10/31/2023.Batch mkr859 mfg date: 9/5/2018, exp date: 8/31/2023.Batch phb848 mfg date: 7/2/2019, exp date: 6/30/2024.A manufacturing record evaluation was performed for the finished device lot number mmq077, and no non-conformances were identified.A manufacturing record evaluation was performed for the finished device lot number mkr859, and no non-conformances were identified.A manufacturing record evaluation was performed for the finished device lot number phb848, and no non-conformances were identified.Additional h3 investigative summary: unopened samples and one empty labeled winding former of product code ep8746, lot mkr859 were received for analysis.The complaint sample was not returned for evaluation.During the visual inspection of eleven 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.An empty labeled winding former of product code ep8746, lot mmq077 was returned for analysis.The issue sample was not received for evaluation.As no needle or suture were returned for evaluation, we are unable to investigate further to the issue of ¿needle detached".An empty labeled winding former of product code ep8746, lot mkr859 was returned for analysis.The issue sample was not received for evaluation.As no needle or suture were returned for evaluation, we are unable to investigate further to the issue of ¿needle detached".An empty labeled winding former of product code ep8746, lot phb848 was returned for analysis.The issue sample was not received for evaluation.As no needle or suture were returned for evaluation, we are unable to investigate further to the issue of ¿needle detached".

• Brand Name: PRLNE BLU 18IN 7-0 D/A BV175-8 EP
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9649520
• Report Number: 2210968-2020-00843
• Device Sequence Number: 16997825
• Product Code: GAW
• UDI-Device Identifier: 10705031206687
• UDI-Public: 10705031206687
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 01/13/2020

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 Model Number: EP8746H
• Device Catalogue Number: EP8746H
• Device Lot Number: MMQ077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2020
• Initial Date Received by Manufacturer: 01/13/2020
• Supplement Date Received by Manufacturer: 01/31/2020
• Initial Report FDA Received Date: 01/30/2020
• Supplement Report FDA Received Date: 02/26/2020
• Patient Sequence Number: 1