MAUDE Adverse Event Report: ETHICON INC. ENDOLOOP LIGATURE WITH COATED VICRYL; LAPROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number EJ10G03

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.The product upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.Additional information was requested and the following was obtained: product code from packaging? - confirmed qty (b)(4) = (b)(4) of lot ae2848 and (b)(4) of ae1086.Was product reprocessed? or is using lights if see thru then they reject.They also place dye ((b)(4)) thru the package.They are random small holes in packaging.

Event Description

It was reported that the patient underwent an unknown procedure on unknown date and the suture was used.Prior to use the nursing staff noticed that there were small holes in the packaging.It is unknown how the procedure was completed.There were no patient consequences reported.

Manufacturer Narrative

Additional information was requested and the following was obtained: please clarify how the packaging was compromised.-hole.Was there any hole, tear, or puncture in the package?- yes.Was the sterility compromised? -yes.Was there moisture in the package? -no.Was there any packaging stain?-no.Was any part of the seal open prior to use? -no only the hole.Was there any foreign matter observed to be in the packaging?- no.What is the quantity of packets that are reportedly compromised? -7 this time, we reported this same problem before.What is the name of the procedure? -na.Was there any adverse patient consequence? -no.Is the product or representative sample (product from the same lot number) available for evaluation? -6 returned.The holes were located in areas where the actual foil presented a multitude of wrinkles caused by foil opening.Unfortunately, no representative unopened sample was returned for evaluation.

• Brand Name: ENDOLOOP LIGATURE WITH COATED VICRYL
• Type of Device: LAPROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-BRAZIL; rodovia presidente dutra, km 1; 54; sao paolo 12240 -908; BR 12240-908
• Manufacturer Contact: kenneth clark ; route 22 westp o box 151; somerville, NJ 08876 ; 9082183547
• MDR Report Key: 5795581
• MDR Text Key: 49625188
• Report Number: 2210968-2016-10462
• Device Sequence Number: 1
• Product Code: GEA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K925914
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: EJ10G03
• Device Lot Number: AE1086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1