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

Catalog Number	332282
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The sample has not yet been received and the investigation is ongoing at this time.A follow-up report will be submitted when the results of the investigation become available.
Event or Problem Description
As reported by the user facility: during the initial placement of the catheter for a patient in labor, the tip of the catheter broke off inside the patient.The facility stated the catheter did not thread easily, however it flushed easily.When the catheter was retracted, the clinician noticed approximately 34 mm of the catheter tip to be missing.The clinician flushed the needle and no remnants were found.The environment area was also checked and no remnants were found.Patient had a neurosurgical consult and underwent a ct scan and a spinal x-ray.No remnants were found on the scans or the x-ray.No further interventions were performed.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).No samples were returned for evaluation in connection with this incident.Multiple unsuccessful attempts were made to obtain a sample.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 a sample and/or any additional pertinent information becomes available, a follow up will be submitted.

• Brand Name: PERIFIX®
• Common Device Name: EPIDURAL ANESTHESIA KIT
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd; allentown PA 18109
• MDR Report Key: 7842509
• Report Number: 2523676-2018-00070
• Device Sequence Number: 1129887
• Product Code: OGE
• UDI-Device Identifier: 04046964178948
• UDI-Public: 04046964178948
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2018

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: 01/31/2020
• Device Catalogue Number: 332282
• Device Lot Number: 0061619575
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/14/2018
• Supplement Date Received by Manufacturer: 08/14/2018
• Initial Report FDA Received Date: 09/04/2018
• Supplement Report FDA Received Date: 09/27/2018
• 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: 33 YR