MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW VASCULAR UNKNOWN; CATHETER, HEMODIALYSIS,IMPLANT

Catalog Number VASCULAR UNKNOWN

Device Problems Crack (1135); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/04/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports the catheter was inserted for one month.The patient was admitted for dialysis and a leak was noted when aspirating the hub prior to dialysis.The hub was changed.

Event Description

The customer reports the catheter was inserted for one month.The patient was admitted for dialysis and a leak was noted when aspirating the hub prior to dialysis.The hub was changed.

Manufacturer Narrative

Qn# (b)(4).The customer returned one connector assembly for evaluation.The catheter body was not returned.The sample contained obvious signs of use in the form of biological material.The extension lines were returned with caps on the hubs.When the hubs were detached, visual examination of the returned connector assembly revealed that both the venous and arterial extension line luer hubs were cracked.The cracks are consistent with over-tightening the luer hub.The luer hubs also contained circular white marks, indicating that excessive torqueing also contributed to the damage.No other defects or anomalies were observed.The connector assembly was leak tested by attaching a 5 ml lab syringe filled with water to each luer hub and depressing the plunger.When both the venous and arterial lines were tested, water leaked out of the cracks in the extension line hub.The ifu provided with this kit cautions the user, "repeated over tightening of bloodlines, syringes and caps will reduce connector life and could lead to potential connector failure".The customer report of cracked luer hubs was confirmed by complaint investigation.The arterial and venous extension line hubs contained large cracks.The hubs contained a circular pattern, indicating excessive torqueing contributed to the damage.A device history record review could not be performed as a material and batch were not provided.Based on the sample received, it was determined that unintentional user error caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW VASCULAR UNKNOWN
• Type of Device: CATHETER, HEMODIALYSIS,IMPLANT
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8336224
• MDR Text Key: 136041421
• Report Number: 1036844-2019-00106
• Device Sequence Number: 1
• Product Code: MSD
• 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: 01/24/2019

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: VASCULAR UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2019
• Initial Date Manufacturer Received: 01/24/2019
• Initial Date FDA Received: 02/13/2019
• Supplement Dates Manufacturer Received: 03/12/2019
• Supplement Dates FDA Received: 03/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1