MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. COMBINED SPINAL & EPIDURAL; SPINAL EPIDURAL ANESTHESIA

Model Number	333197
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Needle Stick/Puncture (2462); Foreign Body In Patient (2687)
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 patient was undergoing thoracotomy for diaphragmatic hernia repair on (b)(6) 2019.Patient received an thoracic epidural and was taped to the patient's back.Patient was moved from stretcher to or bed and provider noticed the catheter had completed sheared off in half.The cause of the catheter shearing appears to have been some tension placed on catheter as the patient was moving.Half of the catheter was still inside the patient taped to her back.As this is a painful procedure, the patient needed a pain control modality beside iv narcotics and as patient had just receive preoperative heparin, another epidural was unable to be placed.Patient received post op truncal nerve block (an additional invasive procedure).
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) used sample without packaging and photos were provided for further evaluation.Based on the evaluation results, the probable root cause of the catheter breakage is believed to have happened during application.The reported defect is not likely to have occurred during the manufacturing process.The following information was provided to the end user: per the ifu: user should refer to ifu which states, "never pull the catheter back through the epidural needle due to the possibility of shearing or kinking the catheter.When removing the catheter, excessive force should never be applied.If the catheter becomes difficult to withdraw, consult standard textbooks for specific techniques." 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: COMBINED SPINAL & EPIDURAL
• Common Device Name: SPINAL EPIDURAL ANESTHESIA
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• MDR Report Key: 9335004
• Report Number: 2523676-2019-00224
• Device Sequence Number: 19457517
• Product Code: OFT
• UDI-Device Identifier: 04046964179327
• UDI-Public: 04046964179327
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 02/20/2020

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 Model Number: 333197
• Device Catalogue Number: 333197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• Initial Date Received by Manufacturer: 11/04/2019
• Supplement Date Received by Manufacturer: 11/04/2019
• Initial Report FDA Received Date: 11/18/2019
• Supplement Report FDA Received Date: 02/20/2020
• 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: Required Intervention