MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW AGBA PICC/DELTA KIT: 1-L 4.5 FR X 50 CM; INTRODUCER, CATHETER

Model Number	IPN037304
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
Customer opened the kits and they had triple lumen piccs in them, not single lumens as they were labeled.The issue was detected prior to patient use.No patient involvement.
Event or Problem Description
Customer opened the kits and they had triple lumen piccs in them, not single lumens as they were labeled.The issue was detected prior to patient use.No patient involvement.
Additional Manufacturer Narrative
Qn# (b)(4).The customer returned two photos for investigation.Visual examination of the photos confirmed the reported complaint.One of the photos showed the product lidstock.The other photo showed that a 3-lumen catheter was provided in the kit.The customer also returned an opened kit for investigation.Visual inspection of the returned kit revealed the catheter provided was a 3-lumen, 6fr 50cm catheter.However, per the bill of materials, the catheter provided in this kit should be a single lumen, 4.5 fr 50cm catheter.The returned catheter body measured 20 3/16" which is not within specification of 20 11/16" - 20 15/16" per product drawing.A device history record review was performed with no relevant findings.The report of an incorrect catheter was confirmed through examination of the received sample.The catheter provided in this kit should be a single lumen, 4.5 fr 50cm catheter; however, the catheter that was returned was a 3-lumen, 6fr 50cm catheter.A device history record review was performed with no relevant findings.Based on the customer description and the sample received, packaging caused or contributed to this event.A non-conformance was initiated to further investigate this complaint issue.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW AGBA PICC/DELTA KIT: 1-L 4.5 FR X 50 CM
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 12740024
• Report Number: 9680794-2021-00581
• Device Sequence Number: 11938052
• Product Code: DYB
• UDI-Device Identifier: 60801902120740
• UDI-Public: 60801902120740
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2021

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
• Device Expiration Date: 09/30/2022
• Device Model Number: IPN037304
• Device Catalogue Number: CDC-45041-VPS2
• Device Lot Number: 13F21H1160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2021
• Supplement Date Received by Manufacturer: 12/06/2021
• Initial Report FDA Received Date: 11/02/2021
• Supplement Report FDA Received Date: 12/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown