MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 7FR X 30CM; CATHETER, PERCUTANEOUS

Model Number IPN032375

Device Problem Migration or Expulsion of Device (1395)

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

Event Date 09/04/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that "the central venous catheter (insertion date (b)(6) 2021) had slipped out of its holder/fixture.The holder itself was intact, but 2 of the 3 lumens were no longer in the vein, 1 lumen (tip of the catheter) was only about 4 mm in the vein.Infusion supply was no longer guaranteed.A new cvc had to be placed under anesthesia." no patient harm reported.The patient's condition is reported as fine.

Event Description

It was reported that "the central venous catheter (insertion date (b)(6) 2021) had slipped out of its holder/fixture.The holder itself was intact, but 2 of the 3 lumens were no longer in the vein, 1 lumen (tip of the catheter) was only about 4 mm in the vein.Infusion supply was no longer guaranteed.A new cvc had to be placed under anesthesia." no patient harm reported.The patient's condition is reported as fine.

Manufacturer Narrative

Qn# (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.

• Brand Name: ARROW CVC SET: 3-LUMEN 7FR X 30CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 12548537
• MDR Text Key: 273843902
• Report Number: 3006425876-2021-00888
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• 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: 09/07/2021

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: IPN032375
• Device Catalogue Number: SW-14703-EK
• Device Lot Number: 71F21C3011
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/07/2021
• Initial Date FDA Received: 09/29/2021
• Supplement Dates Manufacturer Received: 10/14/2021
• Supplement Dates FDA Received: 10/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NOT REPORTED; NOT REPORTED; NOT REPORTED