MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. PACING/PSI KIT: 5 FR 2-L; CATHETER, ELECTRODE RECORDING

Catalog Number AI-07155-KS

Device Problem Packaging Problem (3007)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/22/2021

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

There was no patient involvement.Complaint was reported via email that one of the cardiology fellows sustained a puncture from scalpel #11 that is provided in the temporary pacing catheter with shrouded pins/introducer kit.Dr.Chen explained that most kits contain a sponge that is used to place sharps during emergent procedures.This sponge serves as a temporary sharp's disposal.This particular kit does not include this item.

Event Description

There was no patient involvement.Complaint was reported via email that one of the cardiology fellows sustained a puncture from scalpel #11 that is provided in the temporary pacing catheter with shrouded pins/introducer kit.Dr.Chen explained that most kits contain a sponge that is used to place sharps during emergent procedures.This sponge serves as a temporary sharp's disposal.This particular kit does not include this item.

Manufacturer Narrative

Qn# (b)(4).The product was not returned for investigation.The complaint was reported as "cardiology fellows sustained a puncture from scalpel".The complaint is not able to be confirmed.The root cause of the complaint is undetermined.The complaint is considered isolated.The lot number for the complaint was not reported initially.A photo of an original packaging label was submitted with the complaint and a lot number was identified.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revised risk.

• Brand Name: PACING/PSI KIT: 5 FR 2-L
• Type of Device: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 12338213
• MDR Text Key: 267129007
• Report Number: 3010532612-2021-00249
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 30801902004537
• UDI-Public: 30801902004537
• Combination Product (y/n): N
• PMA/PMN Number: K945229
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/22/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: AI-07155-KS
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/22/2021
• Initial Date FDA Received: 08/18/2021
• Supplement Dates Manufacturer Received: 09/10/2021
• Supplement Dates FDA Received: 09/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NI.; NI.