MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS KIT 2-LUMEN: 12FR X 16CM AN; CATHETER HEMODIALYSIS IMPLANTE

Catalog Number AK-22122-CDC

Device Problem Material Split, Cut or Torn (4008)

Patient Problems Blood Loss (2597); No Known Impact Or Consequence To Patient (2692)

Event Date 09/29/2018

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).Additional information received from user facility: patient intubated for concerns of possible air embolism.There is no information to determine how the blue lumen was severed.No other additional information to report as the customer ((b)(6) - sr.Manager, value analysis) indicates that she was not provided with any additional information.

Event Description

Complaint description: patient bleeding from right ij pheresis catheter, gauze around lumens removed, blue lumen found to be severed.Hemostasis applied to catheter to stop bleeding.Patient intubated for concerns for possible air embolism to brain or lungs.Pheresis catheter removed by ccm.Vaseline gauze and dry gauze dressing applied to site, pressure held for 5 minutes.

Event Description

Complaint description: patient bleeding from right ij pheresis catheter, gauze around lumens removed, blue lumen found to be severed.Hemostasis applied to catheter to stop bleeding.Patient intubated for concerns for possible air embolism to brain or lungs.Pheresis catheter removed by ccm.Vaseline gauze and dry gauze dressing applied to site, pressure held for 5 minutes.

Manufacturer Narrative

Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.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 HEMODIALYSIS KIT 2-LUMEN: 12FR X 16CM AN
• Type of Device: CATHETER HEMODIALYSIS IMPLANTE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8257907
• MDR Text Key: 133486995
• Report Number: 1036844-2019-00017
• Device Sequence Number: 1
• Product Code: MPB
• Combination Product (y/n): N
• PMA/PMN Number: K993933
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/03/2019

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 Catalogue Number: AK-22122-CDC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/03/2019
• Initial Date FDA Received: 01/17/2019
• Supplement Dates Manufacturer Received: 02/20/2019
• Supplement Dates FDA Received: 02/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention