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

Model Number IPN046734

Device Problem Leak/Splash (1354)

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

Event Date 12/17/2021

Event Type  malfunction  

Event Description

Placement of a peridural anesthesia using the loss of resistance technique.No adequate resistance felt when advancing syringe plunger.During inspection of the needle when connecting a nacl syringe and closure of the distal end of the needle it was noted that fluid leaked from the side of the connector.No patient injury.Termination of the procedure and change to a new set.Additional information: there was no visible defect on the outside.The leakage of liquid in case of resistance at the end of the needle occurred at the seam of the plastic elements that were welded together.There was no patient harm; procedure interrupted by attentive user.

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

Placement of a peridural anesthesia using the loss of resistance technique.No adequate resistance felt when advancing syringe plunger.During inspection of the needle when connecting a nacl syringe and closure of the distal end of the needle it was noted that fluid leaked from the side of the connector.No patient injury.Termination of the procedure and change to a new set.Additional information: there was no visible defect on the outside.The leakage of liquid in case of resistance at the end of the needle occurred at the seam of the plastic elements that were welded together.There was no patient harm; procedure interrupted by attentive user.

Manufacturer Narrative

(b)(4).A device history record review was performed on the epidural needle and luer-lock syringe with no relevant findings.The customer reported the needle hub was leaking.The customer returned one empty kit with an epidural needle.The returned needle was visually examined with and without magnification.Visual examination of the returned needle revealed the needle appears used.The cannula of the returned needle is slightly bent.Microscopic examination of the needle revealed biological material can be seen inside the needle's hub.Also, the needle's hub appears to have a crack.No other defects or anomalies were observed.A manual leak test was performed on the returned needle by plugging the cannula tip and connecting a lab inventory syringe to the luer-lock end of the needle and manually injecting water.A leak could be seen coming from the crack that was observed during the visual examination.No other leaks were detected.A corrective action is not required at this time as the root cause for this complaint investigation could not be determined based upon the information provided and the condition of the sample received.The reported complaint of the needle hub leaking was confirmed based on the sample received.Visual examination revealed the needle's hub appeared to have a crack.Functional testing revealed a leak where the crack was observed.A device history record review was performed on the epidural needle and luer-lock syringe with no relevant findings.It is unknown how the needle was handled prior to and during use.The investigation found no evidence to suggest a manufacturing related cause.Therefore, the potential cause of this complaint could not be determined.No further action is required at this time.

• Brand Name: EPIDURAL CATHETERIZATION SET
• Type of Device: ANESTHESIA CONDUCTION CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 13097552
• MDR Text Key: 282934510
• Report Number: 3006425876-2021-01212
• Device Sequence Number: 1
• Product Code: BSO
• UDI-Device Identifier: 10801902030228
• UDI-Public: 10801902030228
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K140110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/21/2021

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 Operator: Health Professional
• Device Expiration Date: 01/24/2023
• Device Model Number: IPN046734
• Device Catalogue Number: UM-05400-B
• Device Lot Number: 71F21B0177
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2021
• Initial Date FDA Received: 12/28/2021
• Supplement Dates Manufacturer Received: 02/15/2022
• Supplement Dates FDA Received: 02/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1