MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW ARTERIAL CATH SET: 18 GA X 8CM; CATHETER, PERCUTANEOUS

Model Number IPN055217

Device Problem Unable to Obtain Readings (1516)

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

Event Date 03/31/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The complaint is reported as: after insertion of the arterial catheter, it was observed that the pressure reading was no longer functional after 72 hours of use.The monitoring of the pressure was then impossible and arterial sampling was performed by puncture.There was no patient injury.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.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.

Event Description

The complaint is reported as: after insertion of the arterial catheter, it was observed that the pressure reading was no longer functional after 72 hours of use.The monitoring of the pressure was then impossible and arterial sampling was performed by puncture.There was no patient injury.The patient's condition is reported as fine.

• Brand Name: ARROW ARTERIAL CATH SET: 18 GA X 8CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11706203
• MDR Text Key: 258912777
• Report Number: 3006425876-2021-00333
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 10801902146394
• UDI-Public: 10801902146394
• 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: 03/31/2021

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: No Information
• Device Model Number: IPN055217
• Device Catalogue Number: SAC-00818
• Device Lot Number: 71F21A1128
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/31/2021
• Initial Date FDA Received: 04/22/2021
• Supplement Dates Manufacturer Received: 05/18/2021
• Supplement Dates FDA Received: 05/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR