MAUDE Adverse Event Report: ETHICON INC. LAPRA-TY SUTURE CLIP UNKNOWN PRODUCT; CLIP, IMPLANTABLE

Catalog Number XA200

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/26/2018

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (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 confirm the product code and product name? is the product code ka200?? or xa200?? lot #? its xa200.Please confirm total qty of packages involved to have reported issue? 4 packages.Was the defect noticed with the outer secondary package or inner primary package? secondary package.Was the product inside the package noticed to be damaged in any way, upon opening package? no, the package present a little defect.Was the sterility of the product inside the damaged package compromised in any way? yes.Was this reported issue noticed with receiving brand new package or after the package had been previously opened and sitting in the storeroom or other location prior to use? when receive a new package.When was this issue noticed? within j&j control or outside j&j control? outside j&j.Was this discovered at the customer level- distributor or hospital or similar facility? hospital.Any samples available to be returned for evaluation? yes, 1 package.

Event Description

It was reported that a patient underwent an unknown procedure on (b)(6) 2018 and absorbable suture clips were used.The hospital had difficulties with the packaging of the clip.It was too fragile, at the lowest pressure tiny fractures are produced only visible against the light.The package was opened and was apparently unscathed, but when examining it against the light, several small perforations were evident, and it had to be discarded.There were no adverse patient consequences reported.Additional information was requested.

• Brand Name: LAPRA-TY SUTURE CLIP UNKNOWN PRODUCT
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8250814
• MDR Text Key: 133196870
• Report Number: 2210968-2019-78426
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: K931492
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: XA200
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1