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

Catalog Number CDC-41541-MPKC

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/28/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported "during insertion of the sheath, the sheath buckled and coiled on itself and was bent.It did not come apart.A new sheath had to be used." no medical intervention required.No patient harm or injury.The patient's current condition is reported as "fine".

Event Description

It was reported "during insertion of the sheath, the sheath buckled and coiled on itself and was bent.It did not come apart.A new sheath had to be used." no medical intervention required.No patient harm or injury.The patient's current condition is reported as "fine".

Manufacturer Narrative

Qn# (b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and potentially relevant findings were identified.Multiple findings were identified for batches 34c22h0277, 34c23e0162 and 34c23f0030 regarding "peel-away sheath tears incorrectly"; however, it cannot be determined if these findings were relevant to the reported event without the device returned for evaluation.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW AGBA PI MIDLINE 1-L: 4.5FR X 15CM
• Type of Device: 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: marling heaton ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18962540
• MDR Text Key: 338757097
• Report Number: 9680794-2024-00288
• Device Sequence Number: 1
• Product Code: PND
• UDI-Device Identifier: 10801902205435
• UDI-Public: 10801902205435
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: CDC-41541-MPKC
• Device Lot Number: 33F23D0743
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.