MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS SET: 2-L 15 FR X 19 CM RETR; CATHETER, HEMODIALYSIS, IMPLA

Catalog Number CS-15192-VF

Device Problems Device Damaged Prior to Use (2284); Connection Problem (2900)

Patient Problem No Patient Involvement (2645)

Event Date 05/03/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports: attempted to connect the lumens to the catheter and could not.

Event Description

The customer reports: attempted to connect the lumens to the catheter and could not.

Manufacturer Narrative

Qn# (b)(4).The customer returned a connector assembly to a hemodialysis catheter.No other components (including the catheter body) were returned.Visual examination of the catheter body could not be performed as it was not returned for investigation.The connector piece was visually examined and no issues were identified.The right cannula tip had dimensions of 0.72" (width) and.134 (length) which were within specifications.The left cannula tip had dimensions of 0.73" (width) and.135 (length) which were within specifications.The returned connector assembly was able to connect to a lab inventory hemodialysis catheter body with no issues.A device history record review was performed and no relevant manufacturing issues were identified.Instruction booklet directs the clinician to insert the hub connection assembly cannula into the lumens of the catheter.The ifu cautions: ensure the hub connection assembly cannula is fully seated into the catheter and that no cannula is visible.Failure to do so could compromise compression of the catheter onto connector and catheter separation could occur.The report that the connector piece could not connect to the catheter could not be confirmed based on the sample received.No issues were found during visual examination and the connector piece was able to connect to a lab inventory hemodialysis catheter body.In addition, a device history record review was performed with no relevant findings identified.Therefore, the probable cause of this complaint could not be determined based upon the information provided and without the catheter being returned.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW HEMODIALYSIS SET: 2-L 15 FR X 19 CM RETR
• Type of Device: CATHETER, HEMODIALYSIS, IMPLA
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8633610
• MDR Text Key: 145848080
• Report Number: 1036844-2019-00619
• 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,health
• Type of Report: Initial,Followup
• Report Date: 05/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: CS-15192-VF
• Device Lot Number: 23F18L0125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2019
• Date Manufacturer Received: 06/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1