MAUDE Adverse Event Report: ETHICON ETHICON PDS II VIOLET MONOFILAMENT; SUTURE NEEDLE

Model Number Z371

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/25/2019

Event Type  malfunction  

Event Description

During abdominal perineal resection/bilateral oophorectomy, while suturing, the tip of the needle broke off.Exhaustive research was made for the piece of needle in the open abdominal wound, but could not be located.Suture needle removed from field.X-rays were negative for needle.No injury to pt known at this time.Ref mfr report: 2210968-2019-82474.

• Brand Name: ETHICON PDS II VIOLET MONOFILAMENT
• Type of Device: SUTURE NEEDLE
• Manufacturer (Section D): ETHICON ; cincinnati OH
• MDR Report Key: 8683328
• MDR Text Key: 147589546
• Report Number: MW5087214
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 1070503060821
• UDI-Public: (01)1070503060821
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: Z371
• Device Catalogue Number: Z371.P32
• Device Lot Number: PCM971
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/14/2019
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 69