MAUDE Adverse Event Report: ETHICON INC. ETHILON 18IN 4-0 BLK S/A PS-1 PRM MP; SUTURE, NONABSORBABLE

Catalog Number EH7957BH

Device Problem Component Incompatible (1108)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformance's were identified.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.Only pictures were received for analysis.Upon visual inspection of the pictures, a sample of product code eh7957b with description of 45 cm of length could be observed.However, no conclusion could be reach on the length of the suture as the sample was not returned for analysis.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Do you know if the customer has any unopened representative samples to return for evaluation? please explain is the problem relating to the labeling or is the problem relating to the length of the suture? is the issue related to incorrect product in the package?.

Event Description

It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.During the procedure, it was noted that the packaging shows 45 cm, but the suture inside the package was 75 cm long.There were no adverse patient consequences.Additional information has been requested.

Manufacturer Narrative

Product complaint #: (b)(4).Additional information was requested and the following was obtained: please explain is the problem relating to the labeling or is the problem relating to the length of the suture? according to customer suture length found inside the foil is 75 cm.According to label suture with 45 cm length should be inside.Is the issue related to incorrect product in the package? wrong product is inside the packages.Only pictures were received for analysis.Upon visual inspection of the pictures, a sample of product code eh7957b with description of 45 cm of length could be observed.However, no conclusion could be reach on the length of the suture as the sample was not returned for analysis.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Retain sample evaluation: from photo evaluation for the retain sample for product code eh7957bh55, lot # mlq481 it is notice that suture has three (3) as required for a 45cm long suture.Per fg retain sample evaluation it is the lot mlq481 was manufactured as per specification for a 45cm length suture.

• Brand Name: ETHILON 18IN 4-0 BLK S/A PS-1 PRM MP
• Type of Device: SUTURE, NONABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 9117545
• MDR Text Key: 195564309
• Report Number: 2210968-2019-88083
• 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: 08/30/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: EH7957BH
• Device Lot Number: MLQ481
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/30/2019
• Initial Date FDA Received: 09/25/2019
• Supplement Dates Manufacturer Received: 09/26/2019
• Supplement Dates FDA Received: 10/25/2019
• Patient Sequence Number: 1