MAUDE Adverse Event Report: ETHICON INC. ETHIBOND EXCEL POLYESTER SUTURE; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number X964H

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/10/2016

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.Additional information was requested and the following was obtained: what is meant by the sterility of the sutures compromised? the paper part of the packaging was degrading, deteriorating and crumbling.Was the sterility compromised? yes, the packaging was yellowing, there were cracks and holes noticed in the packaging.How was the product stored in the hospital? temperature controlled, no humidity, not next to light, stored in a closed pyxis system.Specific number of samples that had packaging compromised? 3 were sent back, however all 22 were removed because of packaging issue.How many procedures? na.Were the sutures deteriorating? no.Resterilized ? no.Were the sutures found to be degraded within the package? no.Was there damage to the sutures within the package? no.Did the device issue occur multiple times during one procedure? it was noted all at one time.Did the device issue occur during multiple procedures? if so, no.What were the procedure names and dates? noticed during inventory, not during a procedure.Please clarify how the package deteriorated.It was found in this condition.Unknown how it occurred.Were any of those events previously reported to ethicon? na received packets, all samples were received unopened.During the evaluation of the envelope were observed that the tyvek and zipper tray of all samples were damaged (broken).Besides, the ink on the paper lid was observed discolored.Likely this condition could be caused if the samples were storage exposure overheating.Therefore investigation was focus in the manufacturing process and there was not any factor that can cause this damage (broken).Additional, the needle/suture combinations were examined and all needles were attached to the suture.The swage area of the needle/sutures was examined for visual inspection attribute defects and no attachment defects were noted.Samples were tested on by needle pull off and tensile strength and all met the requirements.According to the samples condition it was suggest an improper handling of the packets.Since, is concluded that the damage cause did not happened during the batch process.

Event Description

It was reported that during inventory, the paper part of the suture packaging was degrading, deteriorating and crumbling.It was also reported that the packaging was yellowing, there were cracks and holes noticed in the packaging.The suture was not used on the patient.

• Brand Name: ETHIBOND EXCEL POLYESTER SUTURE
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo PR 00754
• Manufacturer Contact: krystina laguna ; route 22 westp o box 151; somerville, NJ 08876 ; 9082183043
• MDR Report Key: 6068061
• MDR Text Key: 58824300
• Report Number: 2210968-2016-14607
• Device Sequence Number: 1
• Product Code: GAT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Catalogue Number: X964H
• Device Lot Number: EDE260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2012
• 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