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

Model Number	IPN919713
Medical Device Problem Codes	Break (1069); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4) n/a other remarks: n/a corrected data: n/a.
Event or Problem 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 or Problem 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".
Additional 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.
Additional Manufacturer Narrative
(b)(4).Udi related data quality updates only.Section d.4.-unique identifier (udi)# corrected to (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.
Event or Problem 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".

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 14 FR X 15 CM
• Common Device Name: 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: angela meister ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18183368
• Report Number: 3006425876-2023-01124
• Device Sequence Number: 15356215
• Product Code: MPB
• UDI-Device Identifier: 00801902100115
• UDI-Public: (01)00801902100115(11)230505(17)261130(10)71F23E0102(21)
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K991431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2023
• Supplement Date Received by Manufacturer: 12/12/2023; Not provided
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 12/13/2023; 10/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male