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 Failure to Advance (2524); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/02/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

The customer reports that the tip of the dilator was too narrow, flattened or crushed.It did not allow the guide to pass through.

Event Description

The customer reports that the tip of the dilator was too narrow, flattened or crushed.It did not allow the guide to pass through.There was no consequence to the patient.

Manufacturer Narrative

(b)(4).The customer returned one dilator for evaluation.Visual examination revealed the dilator tip was severely compressed.The edges of the compressed tip contained white coloration, indicating that they were kinked and creased.A lab inventory guide wire was unable to pass through the dilator, with significant resistance encountered at the compressed tip.A device history record review was performed with no relevant findings.The ifu provided with this kit instructs the user to enlarge cutaneous puncture site with cutting edge of scalpel prior to dilating the skin.The customer report of a damaged dilator tip was confirmed by complaint investigation of the sample received.The returned dilator tip was severely compressed and damaged.A lab inventory guide wire was unable to pass through the returned dilator.A device history record review was performed with no relevant findings.Based on the sample received, manufacturing (tipping) caused or contributed to this event.A non-conformance request has been initiated to further investigate this issue.

• 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: 9849478
• MDR Text Key: 184071178
• Report Number: 3006425876-2020-00257
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 03/06/2020

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: No Information
• Device Expiration Date: 10/02/2020
• Device Catalogue Number: CS-22122-F
• Device Lot Number: 71F18L2304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2020
• Initial Date Manufacturer Received: 03/06/2020
• Initial Date FDA Received: 03/18/2020
• Supplement Dates Manufacturer Received: 04/23/2020
• Supplement Dates FDA Received: 04/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1