MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW RA CATH SET: 20 GA X 1-1/2"; WIRE, GUIDE, CATHETER

Model Number	IPN035914
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The complaint is reported as: "when the package was opened the needle was protruding from the catheter.This was noticed prior to patient contact." no patient involvement reported.
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one opened arterial catheterization kit for evaluation.No signs of use were observed.Visual examination revealed the needle was protruding through the side of the catheter body.When the needle was removed from the catheter, an indentation was observed from the needle compressing the catheter body.The needle exited the catheter body 4 mm from the distal tip.The instructions-for-use provided with this kit instructs the user, "hold catheter in place and remove spring-wire guide assembly.Pulsatile blood flow indicates positive arterial placement".The returned catheter was held in place and the guide wire assembly and needle were able to be removed with minimal resistance.The returned needle was removed and reinserted into the returned catheter multiple times.The needle exited the cut in the catheter every time.A device history record review was performed with no relevant findings.The ifu provided with this kit cautions the user, "do not reinsert needle into catheter to minimize risk of catheter damage." the customer report of a damaged catheter was confirmed by complaint investigation of the returned sample.The needle exited the side of the catheter body rather than the distal tip.A device history record review was performed with no relevant findings.Because the catheter is assembled to the needle during manufacturing , manufacturing likely caused or contributed to this event.A non-conformance request has been initiated to further investigate this issue.
Event or Problem Description
The complaint is reported as: "when the package was opened the needle was protruding from the catheter.This was noticed prior to patient contact." no patient involvement reported.

• Brand Name: ARROW RA CATH SET: 20 GA X 1-1/2"
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11323743
• Report Number: 9680794-2021-00071
• Device Sequence Number: 14286612
• Product Code: DQX
• UDI-Device Identifier: 00801902013248
• UDI-Public: 00801902013248
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 02/11/2021

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: 05/31/2025
• Device Model Number: IPN035914
• Device Catalogue Number: RA-04120
• Device Lot Number: 14F20F0115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2021
• Initial Date Received by Manufacturer: 02/11/2021
• Supplement Date Received by Manufacturer: 03/24/2021
• Initial Report FDA Received Date: 02/12/2021
• Supplement Report FDA Received Date: 03/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1