MAUDE Adverse Event Report: ETHICON INC. TEMP PACING WIRE 24"(60CM) 2-0 BLU; ELECTRODE, PACEMAKER, TEMP

Catalog Number TPW10

Device Problems Break (1069); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/12/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.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.

Event Description

It was reported a patient underwent a valve exchange procedure on (b)(6) 2018 where temporary pacing wire was used.The needle was passing through the package.Product was not used in the patient.Another thread was used.No adverse patient consequences.

Manufacturer Narrative

Product complaint # pc-(b)(4).Date sent to the fda: (b)(4) 2018.

Manufacturer Narrative

Product complaint # pc-(b)(4).An unopened sample of product was returned for analysis.During the visual inspection of unopened sample, a pin hole on the overwrap package was observed.The package was opened and it was verified that the position of the needle was incorrect.It is probable that the tip of the needle went through the paper folder and the overwrap package.A hole outside the package was visible.Therefore, the sterile barrier was compromised.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.Per the sample condition, the assignable cause of compromise of packaging integrity is a pin hole in package.

• Brand Name: TEMP PACING WIRE 24"(60CM) 2-0 BLU
• Type of Device: ELECTRODE, PACEMAKER, TEMP
• 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 154; sao paolo 12240 -908; BR 12240-908
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7868373
• MDR Text Key: 119949681
• Report Number: 2210968-2018-75787
• Device Sequence Number: 1
• Product Code: LDF
• UDI-Device Identifier: 10705031050860
• UDI-Public: 10705031050860
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K980503
• 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,Followup,Followup
• Report Date: 08/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: TPW10
• Device Lot Number: AH6833
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1