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.
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 four photos of a broken needle hub and returned one introducer needle for evaluation.Visual examination revealed multiple large cracks in the needle hub.The cracks also caused a piece of the hub to separate.A functional inspection could not be performed due to the damage on the returned needle hub.A device history record review was performed with no relevant findings.The customer report of a separated needle hub was confirmed by complaint investigation of the returned sample.The needle hub contained multiple large cracks which also partially separated a piece of hub.A device history record review was performed with no relevant findings.Based on the condition of the sample received, design caused or contributed to this event.A capa has previously been initiated to further investigate this issue.

• 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: 11631281
• Report Number: 3006425876-2021-00292
• Device Sequence Number: 3367572
• 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