MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW EPIDURAL CATHETERIZATION SET; ANESTHESIA CONDUCTION CATHETER

Model Number	IPN920769
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "on (b)(6), i placed an epidural catheter for labor analgesia (brand: arrow, flex tip plus epidural catheterization set).As always, i checked the integrity of the device before placement and performed an aspiration test, which was negative, and a test dose, which also yielded negative results.I then secured the epidural catheter with three packs of steri-strips (a total of 9 strips), applied two transparent polyurethane dressings on top, and created a frame using medi fix tape (polyurethane adhesive tape) to ensure the catheter could not become displaced in any way.I completed the dressing to ensure the catheter was not exposed.The catheter functioned correctly throughout the entire duration of labor.I administered the first analgesic bolus and then connected a pump that released analgesic medication every hour.I was later called to remove the device, as it was no longer necessary.At the time of removal, the catheter appeared to be broken in two places, with the metal core exposed over several centimeters.The dressing was neither tampered with nor wet, indicating that the catheter had been functioning properly up until delivery (this was all confirmed by the patient, who reported effective pain relief throughout labor).".
Additional Manufacturer Narrative
(b)(4).The reported complaint of epidural catheter breaking during use was confirmed based upon the sample received.The customer returned two catheter pieces that were separated at the extrusion.None of the catheter appeared to be missing.At the point of separation, the extrusion and coil wire were stretched on the likely proximal piece and was also stretched on the likely distal piece.The ifu for this product warns the user not to apply additional tension if the catheter begins to stretch as there is a risk for separation.A device history record review was performed on the epidural catheter with no relevant findings.Therefore, based upon the condition of the sample received, unintentional user error caused or contributed to this event.
Event or Problem Description
It was reported that: "(b)(6), i placed an epidural catheter for labor analgesia (brand: arrow, flex tip plus epidural catheterization set).As always, i checked the integrity of the device before placement and performed an aspiration test, which was negative, and a test dose, which also yielded negative results.I then secured the epidural catheter with three packs of steri-strips (a total of 9 strips), applied two transparent polyurethane dressings on top, and created a frame using medi fix tape (polyurethane adhesive tape) to ensure the catheter could not become displaced in any way.I completed the dressing to ensure the catheter was not exposed.The catheter functioned correctly throughout the entire duration of labor.I administered the first analgesic bolus and then connected a pump that released analgesic medication every hour.I was later called to remove the device, as it was no longer necessary.At the time of removal, the catheter appeared to be broken in two places, with the metal core exposed over several centimeters.The dressing was neither tampered with nor wet, indicating that the catheter had been functioning properly up until delivery (this was all confirmed by the patient, who reported effective pain relief throughout labor).".

• Brand Name: ARROW EPIDURAL CATHETERIZATION SET
• Common Device Name: ANESTHESIA CONDUCTION CATHETER
• 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, NC 27560
• MDR Report Key: 22313631
• Report Number: 3006425876-2025-00552
• Device Sequence Number: 8794270
• Product Code: BSO
• UDI-Device Identifier: 40801902062510
• UDI-Public: (01)40801902062510(11)240322(17)260228(10)71F24C0789(21)
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K140110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2025

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: 02/28/2026
• Device Model Number: IPN920769
• Device Catalogue Number: JC-05400-DCS
• Device Lot Number: 71F24C0789
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2025
• Supplement Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2024
• 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: NOT REPORTED; NOT REPORTED
• Patient Age: 30 YR
• Patient Sex: Female