MAUDE Adverse Event Report: BD COMBINED SPINAL EPIDURAL TRAY 17G X 3.5"; ANESTHESIA CONDUCTION KIT

Model Number	405828
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/04/2020
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.Initial reporter phone #: unknown.Initial reporter state: address information was not able to be obtained.(b)(6) was used as a place holder based on the user facility¿s location.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that the flat filters are breaking during use with a bd combined spinal epidural tray 17g x 3.5".The following information was provided by the initial reporter: it was reported that flat filters are breaking on post-op patients.
Event or Problem Description
It was reported that the flat filters are breaking during use with a bd combined spinal epidural tray 17g x 3.5".The following information was provided by the initial reporter: it was reported that flat filters are breaking on post-op patients.
Additional Manufacturer Narrative
H.6.Investigation: no sample was returned for analysis and a picture could not be provided.Consequently, the investigation was not able to further evaluate the reported failure mode through a complaint sample analysis.A device history review could not be completed as no batch number was provided.Without a sample, photograph or lot information the investigation was unable to confirm the failure mode nor identify a probable root cause.As the failure mode was unable to be confirmed nor a root cause able to be determined a corrective and/or preventive action could not be identified for this complaint.

• Brand Name: BD COMBINED SPINAL EPIDURAL TRAY 17G X 3.5"
• Common Device Name: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 9872494
• Report Number: 1625685-2020-00029
• Device Sequence Number: 11319068
• 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: DISCRETION
• Number of Events Summarized: 1
• Summary Report (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): 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 405828
• Device Catalogue Number: 405828
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 03/04/2020
• Supplement Date Received by Manufacturer: 03/04/2020
• Initial Report FDA Received Date: 03/24/2020
• Supplement Report FDA Received Date: 07/30/2020
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Other