MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW RA CATH SET: 20 GA X 1-3/4"; CATHETER PERCUTANEOUS

Model Number	IPN035913
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
Qn#: (b)(4).
Event or Problem Description
Customer reported "catheter failed in the patient".It appeared the hub was cracked.No patient harm was reported.The patient's condition is reported as fine.
Event or Problem Description
Customer reported "catheter failed in the patient".It appeared the hub was cracked.No patient harm was reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).The customer returned one arterial catheter for evaluation.The sample contained obvious signs of use in the form of biological material.Visual inspection confirmed the crack in the hub.The total length of the returned catheter (from proximal end of hub to distal end of catheter tip) measured to be 2.75" which is within specifications of 2.715-2.775" per product drawing.The returned catheter was flushed using a water-filled lab inventory syringe.A leak was observed in the crack of the hub.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.No relevant findings were identified.The ifu provided with this kit warns the user, "to minimize the risk of air embolism and blood loss associated with disconnects use only securely tightened luer lock connections." the customer report of a cracked catheter luer hub was confirmed by complaint investigation of the returned sample.One large crack was observed in the hub, which is consistent with over-tightened of connectors to the luer hub.A device history record review was performed based on a potential lot identified in sales history with no relevant findings.Based on the condition of the sample received, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW RA CATH SET: 20 GA X 1-3/4"
• Common Device Name: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 12064413
• Report Number: 9680794-2021-00318
• Device Sequence Number: 17133674
• Product Code: DQY
• UDI-Device Identifier: 00801902027528
• UDI-Public: 00801902027528
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K021120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2021

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 Model Number: IPN035913
• Device Catalogue Number: RA-04020-SP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2021
• Initial Date Received by Manufacturer: 06/09/2021
• Supplement Date Received by Manufacturer: 07/28/2021
• Initial Report FDA Received Date: 06/24/2021
• Supplement Report FDA Received Date: 07/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED.; NOT REPORTED.