MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS KIT: 2-L 14 FR X 20 CM ANTI; CATHETER, HEMODIALYSIS, NON-I

Catalog Number CDC-25142-X1A

Device Problems Break (1069); Physical Resistance/Sticking (4012)

Patient Problems No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)

Event Date 03/21/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reported that during the removal of the guidewire it got stuck and broke off.They were able to retrieve the broken guidewire with no patient harm.

Manufacturer Narrative

Qn# (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.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 customer reported that during the removal of the guidewire it got stuck and broke off.They were able to retrieve the broken guidewire with no patient harm.

• Brand Name: ARROW HEMODIALYSIS KIT: 2-L 14 FR X 20 CM ANTI
• Type of Device: CATHETER, HEMODIALYSIS, NON-I
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8464198
• MDR Text Key: 140300056
• Report Number: 1036844-2019-00333
• 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: 03/21/2019

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: No Information
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: CDC-25142-X1A
• Device Lot Number: 23F18M0180
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/21/2019
• Initial Date FDA Received: 03/29/2019
• Supplement Dates Manufacturer Received: 05/06/2019
• Supplement Dates FDA Received: 05/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1