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

Catalog Number	332081
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).The sample has 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: upon inserting the catheter into the lumbar region of the patient, breakage occurred and a piece of the catheter was retained inside the patient.Neuro-spine was consulted immediately and evaluated the patient before allowing the patient into the or.X-rays were conducted.The physician decided to leave the broken catheter piece in the patient and to monitor the situation.The patient is without symptoms.
Additional Manufacturer Narrative
(b)(4).One (1) used catheter without packaging was returned for evaluation.The sample was forwarded to the manufacturer for further evaluation.Visual examination noted the catheter to be broken off near the tip.Our manufacturer examined the device and it was noted that such damages may occur when the catheter is withdrawn against the cannula bevel which can cause the catheter to shear.The instructions for use states the following: "never pull the catheter through the needle as it may otherwise shear off." based on the results of the sample evaluation, our manufacturer determined that this did not occur during the manufacturing process since the catheters were 100% inspected and no defects were found during the inspection.Therefore, the manufacturer attributed this issue to an application error.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.

• 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: 7754184
• Report Number: 2523676-2018-00057
• Device Sequence Number: 19258158
• Product Code: OGE
• UDI-Device Identifier: 04046964177262
• UDI-Public: 04046964177262
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 08/28/2018

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: 07/31/2019
• Device Catalogue Number: 332081
• Device Lot Number: 0061592519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2018
• Initial Date Received by Manufacturer: 07/16/2018
• Supplement Date Received by Manufacturer: 07/16/2018
• Initial Report FDA Received Date: 08/06/2018
• Supplement Report FDA Received Date: 08/28/2018
• 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: 74 YR