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 Problem Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/07/2020

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).Preliminary evaluation of the returned device indicates the syringe/needle connection not secure in use.

Event Description

The customer reports that the introducer needle cannot be tucked into syringe.

Manufacturer Narrative

Qn#(b)(4).The customer returned one opened kit containing various components including an ars, introducer needle and catheter-over-needle.Visual examination of the components did not reveal any defects or anomalies.The hub of introducer needle fits snug on the nose of the ars syringe.The hub of the introducer needle was connected to the ars syringe.The needle was submerged in water, and aspiration was replicated.The plunger was then depressed and water exited the bevel of the needle.No leaks were detected during aspiration or purging of the water.The connection between the syringe and the needle was compared with another ars syringe and introducer needle from the lab inventory.The returned ars syringe was tested with a lab inventory needle, and the returned needle was tested with a lab inventory ars syringe.No differences were detected.A device history record review was performed with no relevant findings.The customer report of an insecure ars syringe/needle connection could not be confirmed by complaint investigation.No anomalies were identified.The returned syringe and introducer needle was able to aspirate and purge water with no leaks being detected.The connection between the needle and the syringe was also compared to another syringe and needle from lab inventory and no differences were detected.No problem was found with the returned samples.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

The customer reports that the introducer needle cannot be tucked into syringe.

• 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: 10083414
• MDR Text Key: 192024081
• Report Number: 3006425876-2020-00487
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 05/22/2020

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: 02/02/2021
• Device Catalogue Number: CS-22122-F
• Device Lot Number: 71F19E0948
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2020
• Initial Date Manufacturer Received: 05/22/2020
• Initial Date FDA Received: 05/22/2020
• Supplement Dates Manufacturer Received: 06/23/2020
• Supplement Dates FDA Received: 06/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1