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

Catalog Number	332082
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Multiple unsuccessful attempts were made to obtain a sample and lot number.Without the actual device and/or lot number, a thorough investigation could not be performed.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
Per medwatch report (b)(4) per medwatch report, " crna placed the epidural catheter, removed the needle, gave a test dose, taped the catheter in place and started the epidural infusion.Crna has some difficulty threading the epidural catheter.Patient reported having pain, seen by anesthesiologist.Noted catheter didn't appear deep enough in relation to the catheter markings, that it should have been given an epidural space depth of 7 cm, catheter pulled back 1/2 cm, re-taped, patient re-dosed.Re-dose did not have an effect on relieving the labor pain so epidural was removed.On inspection of the epidural catheter, the blue tip end of the catheter was not present, 1/2 of the catheter was sheared off.X-ray of the lumbar spine on (b)(6) 2017.No signs of retained catheter, per neurosurgery clinical note, catheter piece either has come out or is too small to see against the background of the bone.".

• 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: 6882797
• Report Number: 2523676-2017-00138
• Device Sequence Number: 16330099
• Product Code: OGE
• UDI-Device Identifier: 04046964177286
• UDI-Public: 04046964177286
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 08/24/2017

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: 332082
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2017
• Initial Report FDA Received Date: 09/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 23 YR
• Patient Weight: 86