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

Model Number	IPN055200
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Customer reported cracking of needle hub during puncture of subclavian vein.The cracking of the hub caused air to enter the syringe instead of blood.The procedure was repeated with a new needle.No patient harm reported.
Event or Problem Description
Customer reported cracking of needle hub during puncture of subclavian vein.The cracking of the hub caused air to enter the syringe instead of blood.The procedure was repeated with a new needle.No patient harm reported.
Additional Manufacturer Narrative
(b)(4).The actual device was not returned; however, the customer provided two photos for evaluation.The first photo displayed a needle hub with one large crack.The second photo confirmed the product lidstock.A device history record review was performed and no relevant findings were identified.The customer report of a cracked needle hub was confirmed by complaint investigation of the customer supplied photos.A device history record review was performed with no relevant findings.A capa was previously initiated for this issue.The failure investigation report indicates this issue is design-related.

• 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: 11824583
• Report Number: 3006425876-2021-00413
• Device Sequence Number: 1060456
• Product Code: DQY
• UDI-Device Identifier: 10801902146622
• UDI-Public: 10801902146622
• 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): 04/26/2021

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: 09/19/2025
• Device Model Number: IPN055200
• Device Catalogue Number: CV-15703-E
• Device Lot Number: 71F20K0904
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/26/2021
• Supplement Date Received by Manufacturer: 06/15/2021
• Initial Report FDA Received Date: 05/14/2021
• Supplement Report FDA Received Date: 06/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1