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

Catalog Number SAC-01218-PBX

Device Problem Fluid/Blood Leak (1250)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 08/31/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that: "there was a relatively important bleeding at the puncture point during the insertion of the catheter.There was no consequence for the patient.Surgical compressive dressing was applied." the user reports the puncture needle makes a hole larger than the diameter of the catheter, resulting in heavy bleeding.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.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

It was reported that: "there was a relatively important bleeding at the puncture point during the insertion of the catheter.There was no consequence for the patient.Surgical compressive dressing was applied." the user reports the puncture needle makes a hole larger than the diameter of the catheter, resulting in heavy bleeding.

• Brand Name: ARROW ARTERIAL CATH SET: 18GA X 12CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 12584643
• MDR Text Key: 274996166
• Report Number: 3006425876-2021-00928
• 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: 09/14/2021

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 Catalogue Number: SAC-01218-PBX
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/14/2021
• Initial Date FDA Received: 10/06/2021
• Supplement Dates Manufacturer Received: 10/26/2021
• Supplement Dates FDA Received: 10/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: N/A.; N/A.