MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW MULTI-LUMEN/PSI KIT; INTRODUCER CATHETER

Catalog Number AK-21242-CDC

Device Problem Migration (4003)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports: the catheter migrates when the customer gets to icu.The touhy borst connection with the tape for cath gard is not adequate for securing the catheter.Therapy was not delayed or interrupted.

Event Description

The customer reports: the catheter migrates when the customer gets to icu.The "tuohy" borst connection with the tape for cath gard is not adequate for securing the catheter.Therapy was not delayed or interrupted.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW MULTI-LUMEN/PSI KIT
• Type of Device: INTRODUCER CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8413605
• MDR Text Key: 138933744
• Report Number: 9680794-2019-00080
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• PMA/PMN Number: K011761
• 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: 03/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: AK-21242-CDC
• Device Lot Number: 13F18D0242
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1