MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC PI MIDLINE 1-L: 4FR X 20CM; CATHETER, INTRAVASCULAR, THERAPEUTIC

Model Number IPN056907

Device Problems Material Separation (1562); Separation Problem (4043)

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

Event Date 12/05/2023

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).N/a.Other remarks: n/a.Corrected data: n/a.

Event Description

It was reported that " peeling issue with the peelable dilator.Broken/separated".Additional information received states that "the peel-away sheath was removed entirely by cutting it with a bistouri.There were no clinical consequences for the patient".

Manufacturer Narrative

(b)(4), the report that a peel-away did not tear correctly was confirmed through complaint investigation of the returned sample.The customer returned multiple components of a midline kit, including one peel-away sheath, for analysis.Signs-of-use in the form of biological material was observed.Visual analysis revealed that one of the tabs were separated at the location of the hub.A portion of the extrusion was torn along with one tab, causing it to separate.The sheath body length from the tabs to the distal tip measured 2 3/4" via calibrated ruler, which was within the specification limits of 2 5/8"-2 7/8" per the peel-away product drawing.The sheath outer diameter (od) measured 0.0765" via calibrated micrometer which was within the specification limits of 0.075" - 0.081" per the extrusion graphic.R & d unit confirmed that the failure for this complaint was consistent with an extrusion defect.A device history record review was performed, and no relevant findings were identified.Based on the customer report, the sample received, and the comments from r & d, manufacturing caused or contributed to this event.Further investigation has been initiated under teleflex's quality system by the manufacturing site to further investigate this issue.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported that " peeling issue with the peelable dilator.Broken/separated".Additional information received states that "the peel-away sheath was removed entirely by cutting it with a bistouri.There were no clinical consequences for the patient".

• Brand Name: PI MIDLINE 1-L: 4FR X 20CM
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 18410744
• MDR Text Key: 331532126
• Report Number: 3006425876-2023-01286
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/05/2023

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 Operator: Health Professional
• Device Model Number: IPN056907
• Device Catalogue Number: EU-32041
• Device Lot Number: 71F23H1986
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/05/2023
• Initial Date FDA Received: 12/28/2023
• Supplement Dates Manufacturer Received: 01/24/2024
• Supplement Dates FDA Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2023
• 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