MAUDE Adverse Event Report: ETHICON INC. ETHILON BLUE 4.0M 100CM W/NDL; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number W745

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/30/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.

Event Description

It was reported that prior to an unknown procedure on (b)(6) 2019 and suture was to be used.The nurses noticed that suture packet was not sealed correctly.The device was not used on the patient.There were no patient consequences reported.

Manufacturer Narrative

Product complaint # (b)(4).The review of the batch manufacturing records was conducted, and the batch met all finished goods release criteria.Additional h-3 summary: one unopened sample of product code w745, lot mjk308 was received for analysis.During visual inspection of the overwrap packet, the winding former was noted in the overwrap seal area, this caused that sterile barrier was compromising since a section of the seal area was partially open.Per the condition of the sample received the assignable cause of the packaging - integrity is an open seal defect.

• Brand Name: ETHILON BLUE 4.0M 100CM W/NDL
• 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: 8727457
• MDR Text Key: 148968034
• Report Number: 2210968-2019-83186
• 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: 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: W745
• Device Lot Number: MJK308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2019
• Date Manufacturer Received: 06/24/2019
• Patient Sequence Number: 1