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

Catalog Number JC-05400-E

Device Problems Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371)

Patient Problem No Information (3190)

Event Date 10/02/2019

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 during preparation of epidural we observed that the plunger of syringe is not sealed.Impossible to fill up the syringe.The syringe leaked.

Manufacturer Narrative

Qn#(b)(4).Corrected data: please disregard the previous additional manufacturer narrative that was submitted on the follow-up report.Below is the correct data: a device history record review was performed on the lor syringe with no relevant findings.A design history review was performed for part # kz-05501-002 as a part of this complaint investigation.Per eco-051699 (released 03-dec-2018), supplier (preox) made the following changes: kz-05501-002 luer plastic lor syringe: a.Changed plunger material from profax 535 to profax 531 b.Changed to new plunger tool c.Changed to new mold for blue stopper d.Changed molding location for the plunger and the blue stopper as follows.- plunger: from fleimaplastic in germany to gpe, germany - blue stopper: from et, germany to psilkon, germany these effective changes did impact product design and material.A corrective action is not required at this time as the root cause for this complaint investigation could not be determined based upon the information provided and without the actual sample.Complaint verification testing could not be performed as no sample was provided for analysis.A device history record review was performed on the lor syringe with no evidence to suggest a manufacturing related cause.Therefore, the potential cause of the lor syringe leaking could not be determined based upon the information provided and without the sample.

Event Description

It was reported that during preparation of epidural we observed that the plunger of syringe is not sealed.Impossible to fill up the syringe.The syringe leaked.

Event Description

It was reported that during preparation of epidural we observed that the plunger of syringe is not sealed.Impossible to fill up the syringe.The syringe leaked.

Manufacturer Narrative

Qn#(b)(4).Dhr review could not be conducted since the lot number was not provided.The customer returned one unit 528235 visistat 35w 6/box for investigation.The returned stapler was visually examined with and with out magnification.Visual examination of the returned stapler revealed that the sample appears used as there is biological material present on the device.The stapler was received with 8 staples left in the cover block indicating that at least 27 staples were fired by the end user.Reference file (b)(4) for investigation photos.Functional inspection was performed by attempting to fire staples from the returned stapler.Using hand pressure, the trigger was engaged.Upon full engagement of the trigger, the first staple was able to properly form and release.This was repeated two more times with the same result.To simulate insertion into the skin, the stapler was fired into a simulated skin pad.All three staples fired were able to engage and successfully close into the simulated skin pad.The remaining staples were fired from the stapler with no difficulty.Reference file (b)(4) for investigation photos.The ifu for this product, l02644, was reviewed as a part of this complaint investigation.The ifu states "to obtain optimum staple c losure, the trigger must be squeezed all the way in." the reported complaint of "does not grab skin properly" could not be confirmed based upon the sample received.The returned stapler was able to form and release all remaining staples in the cover block.A device history record review was performed on the device with no evidence to suggest a manufacturing related cause.There were no functional issues found with the returned stapler.

• Brand Name: EPIDURAL CATHETERIZATION SET
• Type of Device: ANESTHESIA CONDUCTION CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9233819
• MDR Text Key: 167003379
• Report Number: 3006425876-2019-00842
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• PMA/PMN Number: K140110
• 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: 10/02/2019

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: 05/20/2021
• Device Catalogue Number: JC-05400-E
• Device Lot Number: 71F19E1868
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/02/2019
• Initial Date FDA Received: 10/24/2019
• Supplement Dates Manufacturer Received: 11/19/2019; 11/19/2019
• Supplement Dates FDA Received: 11/22/2019; 11/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1