MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-LUMEN 14 FR X 15 CM; CATHETER, HEMODIALYSIS, NON-I

Model Number IPN919713

Device Problems Break (1069); Gas/Air Leak (2946)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/12/2023

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4) n/a other remarks: n/a corrected data: n/a.

Event Description

It was reported that "needle from the kit failed to work.During insertion of the needle in the jugular vein there were some air leaks.The needle was properly placed in the vein but there was no blood flow, just air.The insertion was done under supervision and needle was puncture correctly.Male patient.Clinical consequences: none.Device replaced".No patient harm or injury.The patient status is reported as "fine".

Event Description

It was reported that "needle from the kit failed to work.During insertion of the needle in the jugular vein there were some air leaks.The needle was properly placed in the vein but there was no blood flow, just air.The insertion was done under supervision and needle was puncture correctly.Male patient.Clinical consequences: none.Device replaced".No patient harm or injury.The patient status is reported as "fine".

Manufacturer Narrative

(b)(4).The customer provided one photo for evaluation.The report of a cracked needle hub could not be confirmed through visual inspection of the provided photo.The customer also returned one 18ga introducer needle and a non-arrow syringe for analysis.Definite signs of use were observed.Visual analysis revealed the needle hub contained one large vertical crack.Several smaller cracks were also observed on the needle hub.Microscopic examination confirmed the damage.A device history record review was performed and no relevant findings were identified.The customer report of a cracked needle hub was confirmed through visual inspection of the returned sample.The returned needle met all relevant dimensional requirements, and a device history record review was performed with no findings relevant to this investigation.Based on these circumstances and the comments from r & d, the root cause of this complaint is design related.Teleflex has identified that this needle hub material is susceptible to cracking when placed under stress (i.E.Pressed onto a tapered luer fitting, sideloaded as the clinician attempts to locate a vessel, etc.) in the presence of liquid alcohol-based disinfectants.A capa was fully implemented 23-aug-2023 using a new alcohol-resistant material to manufacture the needle hub.The manufacturing date for the needle hub involved with this complaint (oct 2022) occurred prior to the capa implementation date.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 14 FR X 15 CM
• Type of Device: CATHETER, HEMODIALYSIS, NON-I
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18183368
• MDR Text Key: 329381291
• Report Number: 3006425876-2023-01124
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 00801902100115
• UDI-Public: 00801902100115
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K991431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/26/2023

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 Model Number: IPN919713
• Device Catalogue Number: CS-12142-CF
• Device Lot Number: 71F23E0102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/26/2023
• Initial Date FDA Received: 11/21/2023
• Supplement Dates Manufacturer Received: 12/12/2023
• Supplement Dates FDA Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male