MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 7 FR X 20 CM; CATHETER PERCUTANEOUS

Model Number	IPN914755
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Customer reported "introducer needle housing breaks (on the connection of the syringe) during cvc insertion via subclavian vein.While drawing blood air starts to enter into the syringe and the procedure is stopped." a new kit was used.No patient harm reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).The customer provided two photos of a cracked needle hub and returned one product lidstock and introducer needle for evaluation.Visual examination revealed two large cracks in the needle hub.The returned needle was functionally tested in accordance with the instructions-for-use (ifu) provided with this kit.The ifu states, "insert introducer needle with attached arrow raulerson syringe into vein and aspirate." the returned introducer needle was connected to a lab inventory ars to functionally test.When the syringe and needle were used to aspirate, air bubbles entered the syringe body.When the syringe and needle were used to expel water, small droplets of water appeared from the cracks in the hub.The hub of the needle was tested with the male luer gage and was within the specified range.This indicates that the luer conforms to iso 594-1:1986.A device history record review was performed and no relevant findings were identified.The ifu provided with this kit was reviewed as part of this complaint investigation.The reported complaint that the introducer needle hub was cracked was confirmed by the complaint investigation.The returned introducer needle contained two cracks in the hub.A device history record review was performed with no relevant findings found.Further investigation of this issue is being conducted under a capa.The capa failure investigation indicates that the probable cause is design related.
Event or Problem Description
Customer reported "introducer needle housing breaks (on the connection of the syringe) during cvc insertion via subclavian vein.While drawing blood air starts to enter into the syringe and the procedure is stopped." a new kit was used.No patient harm reported.The patient's condition is reported as fine.

• Brand Name: ARROW CVC SET: 2-LUMEN 7 FR X 20 CM
• Common Device Name: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11631284
• Report Number: 3006425876-2021-00293
• Device Sequence Number: 3367573
• Product Code: DQY
• UDI-Device Identifier: 10801902158014
• UDI-Public: 10801902158014
• Combination Product (Y/N): N
• Initial Reporter Country: HR
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2021

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 Expiration Date: 11/21/2025
• Device Model Number: IPN914755
• Device Catalogue Number: CV-17702-E
• Device Lot Number: 71F20M1284
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2021
• Initial Date Received by Manufacturer: 03/18/2021
• Supplement Date Received by Manufacturer: 05/04/2021
• Initial Report FDA Received Date: 04/07/2021
• Supplement Report FDA Received Date: 05/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1