MAUDE Adverse Event Report: SEE H10; ANESTHESIA CONDUCTION KIT

Model Number	405828
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Date of event: unknown.The date received by manufacturer has been used for this field.Medical device brand name: 17g x 3.5 in.Bd perisafe¿ weiss epidural needle (fixed wings).Device expiration date: unknown.Initial reporter phone #: an additional phone # was provided as (b)(6).Device manufacture date: unknown.Investigation summary: bd was unable to perform a thorough investigation as no sample or lot number were provided.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Investigation conclusion: bd was not able to duplicate or confirm the customer¿s indicated failure as no sample or lot code was provided.This complaint will be entered into the complaint management system and will be tracked & trended for future occurrences.
Event or Problem Description
It was reported that the tray cse whit27g4.7 we17g3.5 swc x3795 experienced leakage.The following information was provided by the initial reporter: material no.Unknown, batch no.Unknown.There has been some more issues with the epidural catheter inside this cse tray.

• Brand Name: SEE H10
• Common Device Name: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 11408073
• Report Number: 2243072-2021-00695
• Device Sequence Number: 3545275
• Product Code: CAZ
• UDI-Device Identifier: 00382904058289
• UDI-Public: 00382904058289
• Combination Product (Y/N): Y
• 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
• Report Date (Section B): 02/24/2021

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 Model Number: 405828
• Device Catalogue Number: 405828
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2021
• Initial Report FDA Received Date: 03/03/2021
• 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