MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC PI CVC KIT: 3L 7 FR X 16 CM AGB+; CATHETER,INTRAVASCULAR,THERAP

Catalog Number	ASK-42703-PHHN1
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: dr placed a femoral triple lumen central line.Upon initial puncture when the md would draw back on the needle to verify placement in the vein you would expect to get blood back but instead got air back.The hub was visibly damaged/cracked.It was the 18 ga needle that accepts the guidewire.It was cracked and split at the plastic hub portion.I had attached the syringe as i normally do-gently to make it easy to remove and place the wire.We opened another kit and used a new needle.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The customer returned one 18ga introducer needle, one non-arrow 10ml syringe, and a lidstock for analysis.Signs-of-use were observed on the needle cannula.Visual analysis revealed that the needle hub contained one crack on the hub.Microscopic examination confirmed the crack in the introducer needle hub.The returned 10ml syringe does not appear to be a syringe normally packaged within this reported finished good.A device history record review was performed, and no relevant findings were identified.The customer report of a cracked needle hub was confirmed through complaint investigation.Visual inspection revealed cracks on the needle hub.The failure mode identified is consistent with the failure mode investigated per 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.Capa was implemented using a new alcohol-resistant material to manufacture the needle hub.The needle hub from this complaint was confirmed to be made from the old needle hub material.Teleflex will continue to monitor and trend for reports of this nature.Corrected data: section d.4.Unique identifier (udi)# corrected to (b)(4).
Event or Problem Description
It was reported that: dr placed a femoral triple lumen central line.Upon initial puncture when the md would draw back on the needle to verify placement in the vein you would expect to get blood back but instead got air back.The hub was visibly damaged/cracked.It was the 18 ga needle that accepts the guidewire.It was cracked and split at the plastic hub portion.I had attached the syringe as i normally do-gently to make it easy to remove and place the wire.We opened another kit and used a new needle.

• Brand Name: PI CVC KIT: 3L 7 FR X 16 CM AGB+
• Common Device Name: CATHETER,INTRAVASCULAR,THERAP
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19507813
• Report Number: 9680794-2024-00570
• Device Sequence Number: 12618296
• Product Code: FOZ
• UDI-Device Identifier: 10801902144734
• UDI-Public: 10801902144734
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K071538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2024

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
• Device Expiration Date: 07/31/2025
• Device Catalogue Number: ASK-42703-PHHN1
• Device Lot Number: 33F24A1359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2024
• Supplement Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED.; NOT REPORTED.
• Patient Sex: Male