MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. PACING/PSI KIT: 5 FR/6 FR 2-L

Catalog Number AI-07155-IK

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/20/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that when the catheter was in use, it was noted on assessment of site that fluid seemed to be accumulating in the sterile sheath that houses the tvp wire outside of the insertion site/hub.As a result, the staff was able to drain excess fluid from distal end of sterile sheath without incident.There was no report of patient complications, serious injury or death.

Event Description

It was reported that when the catheter was in use, it was noted on assessment of site that fluid seemed to be accumulating in the sterile sheath that houses the tvp wire outside of the insertion site/hub.As a result, the staff was able to drain excess fluid from distal end of sterile sheath without incident.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

(b)(4).No part was returned to teleflex chelmsford for investigation.The reported complaint of "fluid accumulating in sterile sheath" is not able to be confirmed.The root cause of the complaint is undetermined.The specific serial number/lot number was not reported, but a device history record (dhr) review was conducted for the lot numbers shipped to this account with no relevant findings.All devices passed manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revived risk.This will be monitored for any developing trends.Corrected data: the "operator of device" was not mark off during the submission of the initial report.The field is now marked off, as the "operator of device" was a health professional.

• Brand Name: PACING/PSI KIT: 5 FR/6 FR 2-L
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11223113
• MDR Text Key: 229589127
• Report Number: 3010532612-2021-00022
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AI-07155-IK
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1