MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW ARTERIAL CATH. SET: 20 GA X 8CM; CATHETER PERCUTANEOUS

Model Number IPN037640

Device Problem Unable to Obtain Readings (1516)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/26/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

The complaint is reported as: "the arterial catheter is not properly working.The catheter was inserted on (b)(6) 2020 at 5pm.On the (b)(6) 2020 at 8am there was : no measurement curve, no sample possible to make.Consequence: no possibility to perform a hemodynamics monitoring.Patient was there for monitoring the blood gas.The care are painful for patients in rescucitation department." it was reported no medical intervention was required and there was no consequence for the patient.

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: "the arterial catheter is not properly working.The catheter was inserted on (b)(6) 2020 at 5pm.On the (b)(6) 2020 at 8am there was : no measurement curve, no sample possible to make.Consequence: no possibility to perform a hemodynamics monitoring.Patient was there for monitoring the blood gas.The care are painful for patients in rescucitation department." it was reported no medical intervention was required and there was no consequence for the patient.

• Brand Name: ARROW ARTERIAL CATH. SET: 20 GA X 8CM
• Type of Device: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10578100
• MDR Text Key: 208356805
• Report Number: 3006425876-2020-00814
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K862056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: IPN037640
• Device Catalogue Number: SAC-00820-PBX
• Device Lot Number: 71F20E1201
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.; NONE REPORTED.