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

Catalog Number JC-05400-LB

Device Problem Physical Resistance (2578)

Patient Problem Headache, Lumbar Puncture (2186)

Event Date 12/12/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the new needle tuohy, the tip has less curvature than before and as a consequence 18 patients suffered wet needling, the epidural administration broke the ligament of dura mater, during the two last months.Patient complications: strong headaches, which can become chronic.It was reported that the patients are currently doing fine.

Event Description

It was reported that the new needle tuohy, the tip has less curvature than before and as a consequence 18 patients suffered wet needling, the epidural administration broke the ligament of dura mater, during the two last months.Patient complications: strong headaches, which can become chronic.It was reported that the patients are currently doing fine.

Manufacturer Narrative

(b)(4).A device history record review was performed on the epidural needle with no relevant findings.A design history review was performed for part rz-05400-006 as a part of this complaint investigation.Per (b)(4), (closed 31-jul-2015) a new part # was created (rz-05400-006) was created to replace part # kz-05400-006.And the supplier spectra would replace pajunk.Per the manufacturing site (zdar), the new needle was qualified in accordance with bs 6196 (specification for sterile epidural catheters and introducer needles for single use) and have the same design as the originally used epidural needle from pajunk.The curvature angle is the same and no change to the ifu was done.Also during the needle qualification, the needle rz-05400-006 was clinically evaluated and found acceptable.There were no changes announced after switch to production lifecycle.The ifu for this kit, cz-05400-108a; rev.02, was reviewed as a part of this complaint investigation.The ifu suggests "prep puncture site and drape to form sterile field.Perform skin wheal using desired needle.Make a small skin nick of approximately 2 mm at insertion site to help facilitate epidural needle introduction.Where provided, the attachable epidural needle winged hub may be assembled to other remarks: needle prior to insertion.Winged hub can be attached to needle by sliding hub over needle cannula (refer to fig.1) and pushing it firmly onto hub of needle (refer to fig.2).Precaution: winged hub should not be removed after being firmly positioned.This hub is designed for use with needle in this product only.Orient bevel and insert epidural needle.Advance forward until tip is felt embedded in ligamentum flavum.Remove stylet from epidural needle.To aid in determination of location of the epidural space, use hanging drop method or attach appropriate syringe to needle for loss of resistance technique.Aspirate to ensure proper placement of the needle bevel in epidural space.Warning: when blood or spinal fluid is returned in the plunger barrel, the needle has been placed incorrectly.Stop.Remove the needle and attempt new puncture." a corrective action is not required at this time as a potential root cause could not be determined based upon the information provided and without a sample.Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed on the epidural needle with no evidence to suggest a manufacturing related cause.Therefore, the potential cause of the needle tip having less curvature could not be determined based upon the information provided and without a sample.

• Brand Name: EPIDURAL CATHETERIZATION KIT
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7147476
• MDR Text Key: 95913299
• Report Number: 3006425876-2017-00571
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: JC-05400-LB
• Device Lot Number: SEVERAL
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1