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)
Date of Event	04/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device involved has not been received for evaluation and the investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.
Event or Problem Description
As reported by the user facility: it was reported that the catheter tip broke off.Patient was placed in the sitting position with maternal and fetal monitoring.After identifying the l4-l5 inter-spaced based on anatomic landmarks, the skin was sterilely prepped using chlorhexidine and allowed to dry prior to sterile draping.Strict sterile technique was maintained throughout, including the use of a cap, a mask, a sterile fenestrated drape, and sterile gloves.The skin and subcutaneous tissue were anesthetized with 1% lidocaine.An 18-gauge 3-1/2 inch epidural tipped needle was advanced into the epidural space from a midline after 1 attempt.Loss of resistance to preservative-free saline was achieved at 6 cm.A multiorifice catheter was inserted to < 10cm and resistance was met.Then rotated needle 90 degress to the right and attempted to advance catheter and still met resistance.Catheter was then withdrawn at that time and the blue tip was not intact.Patient had an xray and ct and neither showed any evidence of retained foreign body.The results were overread by neurosurgery as well, and they did not see evidence of retained foreign body.No reported patient status change at this time.The patient is being monitored.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).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 database performed for the reported lot number did not reveal any abnormalities or non-conformances of this nature.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: 7449671
• Report Number: 2523676-2018-00022
• Device Sequence Number: 19090190
• Product Code: OGE
• UDI-Device Identifier: 04046964178320
• UDI-Public: 04046964178320
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2018

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: 09/30/2018
• Device Catalogue Number: 332220
• Device Lot Number: 0061582603
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/10/2018
• Supplement Date Received by Manufacturer: 04/10/2018
• Initial Report FDA Received Date: 04/21/2018
• Supplement Report FDA Received Date: 05/21/2018
• 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