MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION KIT: 19 GA; ANESTHESIA CONDUCTION KIT

Catalog Number ASK-05500-JHH1

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/30/2019

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

A patient was admitted for labor and delivery.The anesthesia provider tried to place an epidural catheter.Minimal resistance was met.After loss of resistance the catheter failed to thread, and the needle was removed.At that time, it was noted that the tip of the tuohy needle was bent forward, partially occluding the orifice.It is uncertain whether the tip was bent prior to insertion or during placement.There is concern that the tip should not bend and can create a safety issue as it can shear the catheter upon threading.A similar event reportedly occurred with a different patient in the cardiac operating room recently.We are unsure if there is an issue with this lot.The patient required general anesthesia for c-section.

Event Description

A patient was admitted for labor and delivery.The anesthesia provider tried to place an epidural catheter.Minimal resistance was met.After loss of resistance the catheter failed to thread, and the needle was removed.At that time, it was noted that the tip of the tuohy needle was bent forward, partially occluding the orifice.It is uncertain whether the tip was bent prior to insertion or during placement.There is concern that the tip should not bend and can create a safety issue as it can shear the catheter upon threading.A similar event reportedly occurred with a different patient in the cardiac operating room recently.We are unsure if there is an issue with this lot.The patient required general anesthesia for c-section.

Manufacturer Narrative

(b)(4).A device history record review was performed on the epidural catheter and needle with no relevant findings.The customer reported the epidural needle tip bent during use.The customer returned one epidural needle with stylet and lidstock.Visual examination of the returned needle revealed the needle appears typical.Microscopic examination of the needle appears used as biological material can be seen in the bevel.Also, the bevel revealed the needle tip is bent.The needle bevel appearance is similar to a needle bevel that has been pressed against a hard surface with force.The cannula is also slightly bent.The customer also provided photos that show a needle's no other defects or anomalies were observed.A dimensional inspection was performed on the returned epidural needle.The outer dimension (od) and inner dimension (id) of the returned needle was measured.The od of the returned needle measured 0.058" (c05155), which is within specification of 0.058", 0.0005" per graphic l-05000-007; rev 8.The id measured 0.045" (c05157), which is within specification of 0.044" min per graphic l-05000-007; rev 8.Specifications per graphic l-05000-007; rev 8 was reviewed as a part of this complaint investigation.A review of design change history for part number l-05000-007 was performed as a part of this investigation.No design changes have been made to this product in the past two years that would have led to this complaint.A corrective action is not required at this time as the investigation shows no evidence to suggest a manufacturing related cause.The damage was discovered during use.Therefore, based on the condition of the sample received and the time of discovery, unintentional user error caused or contributed to this event.The reported complaint of the needle being bent during use was confirmed based on the sample received.Visual examination of the returned needle revealed the tip of the needle bevel was bent, which is consistent with damage that can be caused when a needle bevel is pressed against a hard surface.A device history record review was performed on the epidural catheter and needle with no relevant findings.No material issues were found from the vendor for the needle.Therefore, based upon the information provided, the observed needle damage, and the time of discovery, unintentional user error caused or contributed to this event.

• Brand Name: EPIDURAL CATHETERIZATION KIT: 19 GA
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8603515
• MDR Text Key: 144821404
• Report Number: 1036844-2019-00642
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• PMA/PMN Number: K103658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASK-05500-JHH1
• Device Lot Number: 23F18J0108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2019
• Date Manufacturer Received: 06/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1