MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW RA CATH KIT: 20 GA X 1-3/4" (4.5 CM); WIRE, GUIDE, CATHETER

Model Number	IPN036848
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
The inserting clinician reported that the luer lock connection broke off from the tubing (provided in the statlock pouch).No patient harm reported.The patient's condition is reported as fine.
Event or Problem Description
The inserting clinician reported that the luer lock connection broke off from the tubing (provided in the statlock pouch).No patient harm reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4), the customer returned one anchoring device and lidstock for evaluation.Signs of use in the form of biological material were present in the hub and tubing.Visual inspection of the device revealed the luer hub had disconnected from the tubing of the device.A device history record review was performed and did not reveal any relevant findings.The complaint of a luer hub fitting separated was confirmed by visual inspection of the returned sample.The luer hub was found to be separated from the device tubing.A device history record review was performed and did not reveal any relevant findings.Based on the customer description and sample returned, the probable root cause is supplier related issue.A non-conformance was initiated to further investigate this issue.

• Brand Name: ARROW RA CATH KIT: 20 GA X 1-3/4" (4.5 CM)
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 12134076
• Report Number: 9680794-2021-00320
• Device Sequence Number: 4679121
• Product Code: DQX
• UDI-Device Identifier: 10801902117707
• UDI-Public: 10801902117707
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K810675
• 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): 06/16/2021

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: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: IPN036848
• Device Catalogue Number: ASK-04020-LHC
• Device Lot Number: 13F21C0259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2021
• Initial Date Received by Manufacturer: 06/16/2021
• Supplement Date Received by Manufacturer: 07/26/2021
• Initial Report FDA Received Date: 07/08/2021
• Supplement Report FDA Received Date: 07/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1