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

Catalog Number	TPW10
Medical Device Problem Codes	Break (1069); Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/12/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).Date sent to the fda: (b)(4) 2018.
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 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
• 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: 7868373
• Report Number: 2210968-2018-75787
• Device Sequence Number: 19317407
• 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,Followup
• Report Date (Section B): 08/15/2018

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: 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
• Initial Date Received by Manufacturer: 08/15/2018
• Supplement Date Received by Manufacturer: 08/15/2018; 10/08/2018
• Initial Report FDA Received Date: 09/12/2018
• Supplement Report FDA Received Date: 09/12/2018; 11/01/2018
• Patient Sequence Number: 1