MAUDE Adverse Event Report: TRAY CSE WHIT27G4.7 WE17G3.5 SWC X3795; ANESTHESIA CONDUCTION KIT

Model Number 405828

Device Problems Complete Blockage (1094); Leak/Splash (1354)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/25/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Pma/510(k)#: enforcement discretion.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that tray cse whit27g4.7 we17g3.5 swc x3795 catheter was clogged.The following information was provided by the initial reporter: material no: 405828 batch no: unknown (provided 0003177963) it was reported that the epidural catheter in the kit does not seem to be patent; unable to push meds through it.Event description per email states: epidural catheter in kit does not seem to be patent and i cannot push meds through it.

Manufacturer Narrative

The following fields were updated due to additional information: d4: medical device lot #: 0001377963.D4: medical device expiration date: 9/30/2021.H4: device manufacture date: 8/13/2020.H6: investigation: no sample was returned for an evaluation.A dhr review did not identify any manufacturing issues which might have contributed to the failure mode.Additionally, since no samples and no photos were received for evaluation, the investigation was unable to confirm the reported failure mode nor identify any potential issues during manufacture.A probable root cause could not be determined at this time.

Event Description

It was reported that tray cse whit27g4.7 we17g3.5 swc x3795 catheter was clogged.The following information was provided by the initial reporter: material no: 405828; batch no: unknown (provided 0003177963).It was reported that the epidural catheter in the kit does not seem to be patent; unable to push meds through it.Event description per email states: epidural catheter in kit does not seem to be patent and i cannot push meds through it.

• Brand Name: TRAY CSE WHIT27G4.7 WE17G3.5 SWC X3795
• Type of Device: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 11067421
• MDR Text Key: 242827582
• Report Number: 1625685-2020-00101
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00382904058289
• UDI-Public: 00382904058289
• Combination Product (y/n): N
• PMA/PMN Number: SEE H.10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2021
• Device Model Number: 405828
• Device Catalogue Number: 405828
• Device Lot Number: 0001377963
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1