MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS SET: 2-L 15 FR X 23 CM RETR; CATHETER, HEMODIALYSIS, IMPLA

Catalog Number CS-15232-VFE

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/14/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that catheter was placed by general surgeon on (b)(6) in theatre.Next day on starting dialysis a leak was noted on red port.On closer inspection by physician there was no thread on the red port.The top of the catheter was replaced by a car (b)(4) replacement hub.

Event Description

It was reported that catheter was placed by general surgeon on 14/03 in theatre.Next day on starting dialysis a leak was noted on red port.On closer inspection by physician there was no thread on the red port.The top of the catheter was replaced by a car 02800 replacement hub.

Manufacturer Narrative

(b)(4).The customer returned a connector assembly from a chronic hemodialysis catheter for evaluation.The connector was returned with dust caps on both of the extension lines.Visual examination of the luer hubs revealed that the extension line with the red clamp had a deformed luer hub.Only a small portion of the luer thread was present and the edges of the hub were more rounded than normal.The thread portion of the luer was noticeably shorter than the opposite extension line luer hub.The luer hub on the blue clamp extension line was fully formed and appeared normal.No defects or anomalies were observed with the luer hub caps.The luer cap was able to be placed onto the luer hub but was able to be removed without having to screw the cap.R and d sustaining engineering was contacted to determine a possible root cause for the issue and the molding engineer confirmed that the defect is likely a molding issue known as short shot or no-fill.The customer report of a deformed luer hub connector was confirmed through visual examination of the returned sample.Visual examination of the luer hubs revealed that the extension line with the red clamp had a deformed luer hub.Only a small portion of the luer thread was present and the edges of the hub were more rounded than normal.Engineering confirmed that this was a molding defect known as short shot or no-fill.Based on the defect the root cause is manufacturing (molding).A non-conformance request has been initiated to further investigate this issue.

• Brand Name: ARROW HEMODIALYSIS SET: 2-L 15 FR X 23 CM RETR
• Type of Device: CATHETER, HEMODIALYSIS, IMPLA
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7403347
• MDR Text Key: 104711735
• Report Number: 1036844-2018-00111
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• PMA/PMN Number: K141051
• 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: 03/20/2018

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: CS-15232-VFE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2018
• Initial Date Manufacturer Received: 03/20/2018
• Initial Date FDA Received: 04/06/2018
• Supplement Dates Manufacturer Received: 05/09/2018
• Supplement Dates FDA Received: 05/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 37 YR