MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 CM; CATHETER HEMODIALYTSIS NON IMP

Catalog Number CS-22122-F

Device Problems Device Damaged Prior to Use (2284); Material Twisted/Bent (2981)

Patient Problem No Patient Involvement (2645)

Event Date 07/17/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The md was preparing the procedure and checked the product.The md found that the swg (spring wire guide) was bent.A new device was obtained for patient use.

Manufacturer Narrative

(b)(4).The customer returned one swg in the advancer tubing, a 2-l catheter, dilator, ars syringe, a needle, a catheter over needle, a transduction probe and a scalpel for evaluation.The packaging was not returned.The straightener tube and end cap from the swg assembly were also not returned.There was no evidence of use on any of the returned components.Visual examination of the returned swg confirmed the guide wire is kinked at two locations along its body.These sections would not be protected if the straightener tube and end cap were to become dislodged during shipping, indicating that the guide wire may have been damaged during shipment.The distal j-bend was intact.Both welds appeared spherical and fully formed.The returned guide wire contained two distinct kinks along the guidewire body.The kinks were located 565 mm and 574 mm from the proximal end, respectively.The total length of the guide wire measured to be 600 mm which is within specifications of 596-604 mm per product drawing.The outer diameter of the returned guide wire measured to be 0.845 mm which is within specifications of 0.838-0.877 mm per product drawing.The undamaged portions of the returned wire guide passed through the returned 18 ga introducer needle, ars syringe, dilator & distal lumen of the catheter with minimal resistance.A manual tug test confirmed the distal and proximal welds were fully attached.A device history record review was performed with no relevant findings.The instructions for use (ifu) provided with the kit informs the user, "do not use if package has been previously opened or damaged." the customer report of guide wire damage before use was confirmed by complaint investigation of the returned sample.The sample passed all relevant dimensional and functional testing, and a device history record review was performed with no relevant findings.The guide wire was returned within its advancer tubing; however the end cap and straightener tube were not attached or returned.The tubing showed no kinks or stress marks.The portions of the guide wire that were kinked were not protected by the advancer tubing if the straightener tube and end cap were to become dislodged during shipping.Based on the condition of the guide wire and the report that the damage was observed before use, storage and shipping caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The md was preparing the procedure and checked the product.The md found that the swg (spring wire guide) was bent.A new device was obtained for patient use.

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 CM
• Type of Device: CATHETER HEMODIALYTSIS NON IMP
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10350048
• MDR Text Key: 202039150
• Report Number: 3006425876-2020-00664
• 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: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 07/20/2020

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 Expiration Date: 07/03/2021
• Device Catalogue Number: CS-22122-F
• Device Lot Number: 71F19J0596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Initial Date Manufacturer Received: 07/20/2020
• Initial Date FDA Received: 07/31/2020
• Supplement Dates Manufacturer Received: 09/03/2020
• Supplement Dates FDA Received: 09/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1