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

Model Number	405828
Medical Device Problem Codes	Complete Blockage (1094); Leak/Splash (1354)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 11067421
• Report Number: 1625685-2020-00101
• Device Sequence Number: 11422145
• Product Code: CAZ
• UDI-Device Identifier: 00382904058289
• UDI-Public: 00382904058289
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: SEE H.10
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2021

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 11/25/2020
• Supplement Date Received by Manufacturer: 05/21/2021
• Initial Report FDA Received Date: 12/23/2020
• Supplement Report FDA Received Date: 06/05/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1