MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AGBA PI MIDLINE 1-L: 4.5FR X 15CM; MIDLINE CATHETER

Catalog Number	CDC-41541-MPKB
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "our picc nurse opened the midline kit for procedure and found the probe cover had a tear in it." additional information received reports the transducer cover had the tear instead.This was found prior to use.There was no patient involvement.
Additional Manufacturer Narrative
Qn# (b)(4).The customer returned one transducer cover and sticker label for analysis.Signs of use were observed in the transducer cover.Initial visual inspection revealed no obvious defects or anomalies.After functionally testing the cover, one tear was observed at the bottom of the cover.The appearance of the tear is consistent with unintentional use error.The transducer cover was filled with water to identify any potential leaks.Once filled, water was found leaking from a tear at the bottom of the transducer cover.A device history record review was performed and no relevant findings were identified.The customer report of a leak in the transducer cover was confirmed through investigation of the returned sample.Visual and functional inspections revealed a tear in the transducer cover.The appearance of the tear is consistent with unintentional use error during use.Therefore, based on the customer report and the sample received, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend on reports of this nature.
Event or Problem Description
It was reported "our picc nurse opened the midline kit for procedure and found the probe cover had a tear in it." additional information received reports the transducer cover had the tear instead.This was found prior to use.There was no patient involvement.

• Brand Name: ARROW AGBA PI MIDLINE 1-L: 4.5FR X 15CM
• Common Device Name: MIDLINE CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• 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: 20350461
• Report Number: 9680794-2024-00967
• Device Sequence Number: 12775889
• Product Code: PND
• UDI-Device Identifier: 10801902205411
• UDI-Public: (01)10801902205411(11)240612(17)260131(10)33F24D0426(21)
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K161313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2024

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: 01/31/2026
• Device Catalogue Number: CDC-41541-MPKB
• Device Lot Number: 33F24D0426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2024
• Supplement Date Received by Manufacturer: 10/11/2024
• Initial Report FDA Received Date: 10/02/2024
• Supplement Report FDA Received Date: 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED.; NONE REPORTED.
• Patient Sex: Unknown