MAUDE Adverse Event Report: ETHICON INC. ETHILON SUTURE 18" (45CM) 5-0 BLK; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number 1832G

Device Problem Component Incompatible (1108)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/20/2019

Event Type  malfunction  

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.Additional information was requested and the following was obtained: please explain the issue.Was the needle shaped half circle but appeared distorted or the needle had completely different shape; for example, straight? no further information is available.Did the 4 involved devices come from 1 box of sample? no further information is available.Are actual devices being returned? yes.Device return status/ follow up when we send the sample to you, we will let you know its return date and tracking number.No further information will be provided.Events reported in: 2210968-2019-87643, 2210968-2019-87646, 2210968-2019-87647.

Event Description

It was reported that a patient underwent an unknown surgery on (b)(6) 2019 and suture was used.During the procedure, when opening the package, it was found that the shape of needle was not 1/2 circle.The product was not used for the patient.There were no adverse consequences to the patient.No additional information was provided.

Manufacturer Narrative

(b)(4).Date sent to the fda: 10/30/2019.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional: it was reported product mix / incorrect component.One unused opened sample of product code 1832, lot pbq525 was received for analysis.During visual inspection of the sample, the swage and attachment area were noted to be as expected.The body needle was examined and the curve is smooth and continue.In addition, the needle was compared with the specification and meet the curve tolerance shadow lines and ½ circle.Also, the suture was dispensed without problems and examined along of the strand and no defects or damage were observed.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.According to the sample condition, no product mix / incorrect component was found.

• Brand Name: ETHILON SUTURE 18" (45CM) 5-0 BLK
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 9075284
• MDR Text Key: 158847759
• Report Number: 2210968-2019-87644
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: 1832G
• Device Lot Number: PBQ525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2019
• Date Manufacturer Received: 10/03/2019
• Patient Sequence Number: 1