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

Catalog Number	332220
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).It was confirmed that the device involved is not available for evaluation.Without the actual device and/or lot number, further evaluation of the complaint is not possible.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.
Event or Problem Description
As per medwatch number (b)(4): patient presented in labor.An epidural block was performed for labor analgesia.The catheter was inserted with out difficulty.After the newborn was delivered, the catheter was attempted to be removed, but the anesthesiologist met resistance.He had the patient lean forward in hopes to dislodge the catheter, but it broke.Neurosurgery was called and the patient opted to have the broken piece of catheter surgically removed.A ct scan revealed that the broken piece of catheter was between the l4 and l5 and was midline in the lamina.The surgeon noted that the catheter was tight between the bones and some portion of the bone needed to be removed in order to free the catheter.Approximately 6cm piece of catheter was removed from the patient.She recovered without incident and was discharged home on post-partum day 2.

• 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: 8781003
• Report Number: 2523676-2019-00112
• Device Sequence Number: 16616811
• Product Code: OGE
• UDI-Device Identifier: 04046964178320
• UDI-Public: 04046964178320
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/11/2019

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 Catalogue Number: 332220
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2019
• Initial Report FDA Received Date: 07/11/2019
• 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: 25 YR
• Patient Weight: 100