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

Catalog Number	TPW10
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).The device history records were reviewed and the manufacturing criteria were 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.Additional information was requested and the following was obtained: has the primary packaging been damaged with a cut / crevice / hole exposing the needle tip and affecting the sterility of the product? or from others? explain.Answer: the package was damaged with hole exposing the tip of the needle.This package was taken from the newly opened box? answer: the customer could not inform.What was the condition of the external box? answer: the customer was not able to tell the external condition of the box.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2018 and a temporary pacing wire was used.Prior to using on the patient, it was noticed that the tip of the needle was exposed through the package.It was not used in the patient.Additional information was requested.
Additional 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 tyvek of overwrap was observed; due to the tip of the needle it sees exposed outside the package.Therefore, compromised the sterile barrier.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 packaging integrity, is pin hole on package.

• Brand Name: TEMP PACING WIRE 24"(60CM) 2-0 BLU
• Common Device Name: ELECTRODE, PACEMAKER, TEMP
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7700265
• Report Number: 2210968-2018-74501
• Device Sequence Number: 903684
• Product Code: LDF
• UDI-Device Identifier: 10705031050860
• UDI-Public: 10705031050860
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K980503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: TPW10
• Device Lot Number: AH3272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2018
• Initial Date Received by Manufacturer: 06/25/2018
• Supplement Date Received by Manufacturer: 10/11/2018
• Initial Report FDA Received Date: 07/18/2018
• Supplement Report FDA Received Date: 11/07/2018
• Patient Sequence Number: 1