MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARTERIAL CATH SET: 18GA X 12CM; CATHETER, PERCUTANEOUS

Model Number IPN030324

Device Problems Break (1069); Material Frayed (1262)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/19/2019

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

The customer reports that during extraction the device frayed and was broken.The device was removed without incident.

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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

Event Description

The customer reports that during extraction the device frayed and was broken.The device was removed without incident.

• Brand Name: ARTERIAL CATH SET: 18GA X 12CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9757885
• MDR Text Key: 181368148
• Report Number: 3006425876-2020-00180
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K093050
• 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: 02/07/2020

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 Expiration Date: 01/17/2023
• Device Model Number: IPN030324
• Device Catalogue Number: SAC-01218
• Device Lot Number: 71F18A1651
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/07/2020
• Initial Date FDA Received: 02/26/2020
• Supplement Dates Manufacturer Received: 03/27/2020
• Supplement Dates FDA Received: 03/27/2020
• Patient Sequence Number: 1
• Patient Age: 78 YR