MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. STIMUQUIK: 22G X 5CM (2") PNB NEEDLE; ANESTHESIA CONDUCTION KIT

Catalog Number AB-22050-SS

Device Problems Fluid/Blood Leak (1250); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/07/2019

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

It was reported that the stimulating pnb needle of the catheter is leaking; there was a hole at the level of the insertion of the catheter and the injection system next to the neurostim.There may have been direct consequences for the patient (air injection, modified injected dose, degraded asepsis) and indirect (altered quality of ultrasound guidance by injection of air with less echogenicity).It happened at least with 3 different catheters with this lot# and at least 2 different doctors.

Manufacturer Narrative

Qn#(b)(4).A device history record was not available for review.The customer reported a leak coming from the needle/tubing.The customer returned one sealed unused stimuquik needle from the same lot # as reported on the complaint (b)(4).No actual complaint sample was received.The stimuquik needle was removed from the seal package and was visually examined with and without magnification.Visual examination of the returned stimuquik needle revealed that the sample appears typical with no observed defects or anomalies.A corrective action is not required at this time as the complaint could not be confirmed based upon the information provided and without the actual complaint sample.The representative sample received was functionally tested and visually inspected with no issue found.The reported complaint of the needle's tubing leaking could not be confirmed based on the sample received.The actual complaint sample was not returned; only a representative sample was received.The returned sample was visually inspected and functionally tested with no issue found.A device history record was not available for review.A potential root cause could not be determined based upon the information provided or without the actual complaint sample.

Event Description

It was reported that the stimulating pnb needle of the catheter is leaking; there was a hole at the level of the insertion of the catheter and the injection system next to the neurostim.There may have been direct consequences for the patient (air injection, modified injected dose, degraded asepsis) and indirect (altered quality of ultrasound guidance by injection of air with less echogenicity).It happened at least with 3 different catheters with this lot# and at least 2 different doctors.

Manufacturer Narrative

Qn#(b)(4).After an additional medical review, a determination was made to re-classify the complaint as a malfunction.Complaint (b)(4) is being reported as a malfunction.There was no serious injury.

• Brand Name: STIMUQUIK: 22G X 5CM (2") PNB NEEDLE
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8931879
• MDR Text Key: 155553563
• Report Number: 3011137372-2019-00276
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• PMA/PMN Number: K173321
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 08/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AB-22050-SS
• Device Lot Number: 19E07-1-P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2019
• Date Manufacturer Received: 09/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening