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

Catalog Number JC-05400-B

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 04/26/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During the catheter insertion a decision was made to remove it.During the removal the catheter tip broke at the 4 cm level.Additional information indicates that an mri was performed which showed a foreign body of 2cm of length in the interspinous space.No intervention was performed.The patient's condition is unknown.

Manufacturer Narrative

(b)(4).A device history record review could not be performed as no lot number was provided by the customer.A review of sales history data was performed to obtain a lot number.However, no record could be found.The customer reported the catheter separated when the catheter was being removed from the patient.The customer returned one snaplock adapter and one catheter piece.The components were received connected together (reference files (b)(4)).The returned catheter piece was visually examined with and without magnification.Visual examination of the returned snaplock adapter revealed that the snaplock appears typical with no observed defects or anomalies.Visual examination of the returned catheter revealed the distal tip is not present on the returned catheter piece and the extrusion appears to have been separated at the distal tip.The extrusion and coils on the likely most distal end are stretched; however, the coil does not stretch beyond the extrusion at the point of separation.The proximal side of the catheter appears to be intact as no damage was observed.The extrusion and coils appear to be damaged at approximately 18.5cm and 79cm from the proximal end.The catheter appears to have been used as adhesive other remarks: residue is present on the catheter body exterior.No other defects or anomalies were observed (reference files (b)(4)).A dimensional inspection was performed on the returned catheter piece using a ruler ((b)(4)).The returned catheter extrusion piece measures approximately 108cm.Although, the specification per graphic (b)(4) rev.8 indicates that the proper length of an epidural catheter is 88.5-91.5 cm, part of the catheter is missing based on the condition of the sample received.The extrusion and coils are extremely stretched at the likely distal most end of the returned catheter.Specifications per graphic (b)(4); rev.8 were reviewed as a part of this complaint investigation.The ifu for this kit, (b)(4); rev.02, was reviewed as a part of this complaint investigation.The ifu warns the user, "never tug or quickly pull on catheter during removal from patient to reduce risk of catheter breakage.Do not apply additional tension on the catheter if catheter begins to stretch excessively.Reposition patient to open the vertebral interspaces and re-attempt removal if resistance is encountered or if catheter stretches excessively during removal.During epidural catheter removal , the literature indicates a force of approximately 1/3 of a pound is all that is necessary to exert if patient is properly positioned in the recommended lateral neutral position." a corrective action is not required at this time as the condition of the sample received indicates operational context caused or contributed to this event.The reported complaint of the epidural catheter breaking during removal was confirmed based upon the sample received.The returned catheter was missing the distal end.The catheter showed signs of stretching at the point of separation at the likely most distal end.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.The ifu for this product also indicates not to alter the catheter in anyway.Therefore , based upon the condition of the sample received and the observed evidence of stretching at the point of separation, operational context caused or contributed to this event.

Event Description

During the catheter insertion a decision was made to remove it.During the removal the catheter tip broke at the 4 cm level.Additional information indicates that an mri was performed which showed a foreign body of 2cm of length in the interspinous space.No intervention was performed.The patient's condition is unknown.

• Brand Name: EPIDURAL CATHETERIZATION SET
• Type of Device: ANESTHESIA CONDUCTION KIT
• 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: 6070503
• MDR Text Key: 58936826
• Report Number: 3006425876-2016-00339
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: JC-05400-B
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1