MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 7FR X 20CM; CATHETER, PERCUTANEOUS

Model Number	IPN914755
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Customer reported "cracking of the needle hub during the puncture of subclavian vein which causes the air to enter the syringe instead of the blood.The procedure has to be stopped and then repeated with a new set." it was reported there was no damage observed on the needle hub prior to the puncture.There was no patient harm.The patient's condition is reported as fine.
Event or Problem Description
Customer reported "cracking of the needle hub during the puncture of subclavian vein which causes the air to enter the syringe instead of the blood.The procedure has to be stopped and then repeated with a new set." it was reported there was no damage observed on the needle hub prior to the puncture.There was no patient harm.The patient's condition is reported as fine.
Additional Manufacturer Narrative
Qn#(b)(4).The actual device was not returned; however, the customer provided two photos for evaluation.The first photo displayed the product lidstock.The second photo displayed an introducer needle.At least one crack was observed on the hub.A device history record review was performed and no relevant findings were identified.The customer report of a cracked needle hub was confirmed by visual inspection of the customer supplied photos.The needle hub contained at least one large crack.A device history record review was performed with no relevant findings.A capa was previously initiated to investigate this issue.The root cause was determined to be a design issue.

• Brand Name: ARROW CVC SET: 3-LUMEN 7FR X 20CM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 12132680
• Report Number: 3006425876-2021-00601
• Device Sequence Number: 909639
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2021

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: No Information
• Device Expiration Date: 01/21/2026
• Device Model Number: IPN914755
• Device Catalogue Number: CV-17702-E
• Device Lot Number: 71F21B0058
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/16/2021
• Supplement Date Received by Manufacturer: 08/03/2021
• Initial Report FDA Received Date: 07/07/2021
• Supplement Report FDA Received Date: 08/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1