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

Model Number IPN920769

Device Problems Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)

Patient Problems Discomfort (2330); Inadequate Pain Relief (2388)

Event Date 11/01/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Reported issue: incident occurred on (b)(6) 2022.The epidural analgesia catheter was inserted in the female patient that was giving birth.Insertion done without any difficulty.The catheter was attached as usual with a transparent sterile dressing at the level of the lumbar puncture bridge and attached to the patient's shoulder with a mefix-type dressing.The patient was not agitated, she was not rubbing her back excessively on the bed.Observing the inefficiency of the epidural analgesia 5 hours after insertion, the midwife examined the puncture site searching for a possible leak from the catheter.She discovered a cut of the catheter 30 cm from the tip that is inside patient.I removed the catheter and inserted a new analgesia catheter.There was loss of analgesia and patient discomfort but no part of the catheter was left in the patient, no breach.

Manufacturer Narrative

Qn#(b)(4).The customer reported the catheter was leaking.The customer returned one opened kit.The epidural catheter was removed and visually examined with and without magnification.Visual examination of the returned catheter revealed the catheter was returned in two pieces.The catheter appears to have been cut.Also, both the proximal and distal ends of the returned catheter pieces appear to be intact.The catheter appears to have been used as biological material can be seen on the inner coils and adhesive on the other extrusion.No other defects or anomalies were observed.A dimensional inspection was performed on the catheter using a ruler.None of the catheter appears to be missing.The catheter is within specification.Functional inspection was performed on the returned sample.A functional leak test was performed per amrq-000017 section 7.5; rev.10 using the returned catheter proximal piece and snaplock assembly with the lab leak tester.No leak was observed.The same test was performed on the returned catheter distal piece with the same results.A device history record review was performed on the epidural catheter with no relevant findings.The ifu for this kit, e-17019-110a; rev.2, was reviewed as a part of this complaint investigation.The ifu cautions the user, "do not alter the catheter or any other kit/set component during insertion, use or removal (except as instructed)." a corrective action is not required at this time as the condition of the sample received indicates unintentional user error caused or contributed to this event.The reported complaint of the catheter leaking could not be confirmed based on evaluation of the sample received.Visual inspection revealed the catheter was returned in two pieces as it appears the catheter had been cut.However, no leaks were detected during the functional inspection of the returned epidural catheter pieces.A device history record review was performed on the epidural catheter with no evidence to suggest a manufacturing related issue.Therefore, based upon the condition of the sample received, unintentional user error caused or contributed to this event.No further action is required at this time.

Event Description

Reported issue: incident occurred on (b)(6) 2022.The epidural analgesia catheter was inserted in the female patient that was giving birth.Insertion done without any difficulty.The catheter was attached as usual with a transparent sterile dressing at the level of the lumbar puncture bridge and attached to the patient's shoulder with a mefix-type dressing.The patient was not agitated, she was not rubbing her back excessively on the bed.Observing the inefficiency of the epidural analgesia 5 hours after insertion, the midwife examined the puncture site searching for a possible leak from the catheter.She discovered a cut of the catheter 30 cm from the tip that is inside patient.I removed the catheter and inserted a new analgesia catheter.There was loss of analgesia and patient discomfort but no part of the catheter was left in the patient, no breach.

• Brand Name: EPIDURAL CATHETERIZATION SET
• Type of Device: 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: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 15868591
• MDR Text Key: 304345822
• Report Number: 3006425876-2022-01018
• Device Sequence Number: 1
• Product Code: BSO
• UDI-Device Identifier: 10801902197631
• UDI-Public: 10801902197631
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K140110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/07/2022

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: 04/30/2024
• Device Model Number: IPN920769
• Device Catalogue Number: JC-05400-DCS
• Device Lot Number: 71F22E1654
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/07/2022
• Initial Date FDA Received: 11/28/2022
• Supplement Dates Manufacturer Received: 12/21/2022
• Supplement Dates FDA Received: 12/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2022
• 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
• Treatment: NONE REPORTED.; NONE REPORTED.
• Patient Sex: Female