MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3L 7 FR X 16 CM; CATHETER PERCUTANEOUS

Model Number	IPN918807
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "during the insertion of the cvc, the plastic hub is cracked, the needle cannot be used.Clinical consequence: delay in treatment.Kit changed." patient condition stable.There was no other patient harm or consequence.
Additional Manufacturer Narrative
(b)(6) the customer returned multiple components of a cvc kit for analysis, including one introducer needle and arrow raulerson syringe (ars) for analysis.Definite signs of use in the form of biological material were observed within the needle.Visual analysis revealed that the needle hub contained multiple scratches and cracks.It was also noted that one crack along the length of the hub body.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 failure mode identified is consistent with the failure mode investigated under a previously opened capa.Based on the capa investigation, 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.The 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 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 "during the insertion of the cvc, the plastic hub is cracked, the needle cannot be used.Clinical consequence: delay in treatment.Kit changed." patient condition stable.There was no other patient harm or consequence.

• Brand Name: ARROW CVC SET: 3L 7 FR X 16 CM
• Common Device Name: CATHETER PERCUTANEOUS
• 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: 18590646
• Report Number: 3006425876-2024-00030
• Device Sequence Number: 6660470
• Product Code: DQY
• UDI-Device Identifier: 00801902102133
• UDI-Public: 00801902102133
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2024

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: IPN918807
• Device Catalogue Number: CS-12703-E
• Device Lot Number: 71F23C1491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2024
• Supplement Date Received by Manufacturer: 02/27/2024
• Initial Report FDA Received Date: 01/26/2024
• Supplement Report FDA Received Date: 02/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2023
• 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: Unknown