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	07/02/2019
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: customer reports catheter retained in patient.It was stated that the catheter was placed about noon on (b)(6) 2019 and removed about 5:30 pm and the tip was noted to be missing.End user believes that about 5mm of the tip retained in patient.It looks like the catheter broke at the lowest opening.No signs and symptoms of any issue with retained piece of catheter.At this time they are not planning on removal.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Two (2) used closed tip catheters 20g non sterile without packaging was returned by the customer for evaluation.Visual examination of the two catheters notes that one is intact with no defects and the other is missing the tip.The sample and all information of this incident was forwarded to our manufacturer for evaluation.Our manufacturer examined the device and it was noted that such damages may occur when the catheter will be withdrawn against the cannula bevel and thereby shear off.We have advised the end user to refer to the instructions for use were it states: "never pull the catheter through the needle as it may otherwise shear off." 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.

• 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: 8802418
• Report Number: 2523676-2019-00115
• Device Sequence Number: 320761
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2019

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: Health Professional
• Device Catalogue Number: 332220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2019
• Initial Date Received by Manufacturer: 07/03/2019
• Supplement Date Received by Manufacturer: 07/03/2019
• Initial Report FDA Received Date: 07/18/2019
• Supplement Report FDA Received Date: 08/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1