MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. 555083; EPIDURAL ANESTHESIA KIT

Catalog Number	555083
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).As confirmed by the user facility, no sample is available for evaluation.Without the actual device, a thorough investigation could not be performed.Review of the discrepancy management system (dsms) database performed for the reported lot number revealed no abnormalities or non conformances noted during in process or final product inspection.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.
Event or Problem Description
As reported by the user facility: as the doctor was performing the epidural, questionable loss of resistance occurred.The catheter was advanced to about 22 cm.As the catheter was being withdrawn, some resistance was felt and the doctor gently tugged on the catheter.After the withdrawal of the catheter, the doctor noticed it was cut at the 9 cm mark.The tuohy needle was not checked to see if the catheter was left in the needle which could have been possible since the tuohy needle is 10 cm long.The catheter did not go intrathecally.The procedure was then aborted.The patient had an uneventful vaginal delivery shortly thereafter.A cat scan was conducted but failed to locate the catheter.The doctor consulted the neurosurgeon and the neurosurgeon stated to do no further intervention.The patient has had no symptoms or complaints.

• Brand Name: 555083
• Common Device Name: EPIDURAL ANESTHESIA KIT
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd; allentown PA 18109
• MDR Report Key: 7432340
• Report Number: 2523676-2018-00021
• Device Sequence Number: 11148667
• Product Code: OGE
• UDI-Device Identifier: 04046964313493
• UDI-Public: 04046964313493
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/16/2018

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: Health Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: 555083
• Device Lot Number: 0061594205
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2018
• Initial Report FDA Received Date: 04/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 31 YR