MAUDE Adverse Event Report: DESIGN OPTIONS®; EPIDURAL ANESTHESIA KIT

Model Number	552175
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	07/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).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: end user reports: catheter broke.Detailed inquiry description: the catheter might have been pulled on and then broke and frayed.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) used catheter and connector were received for evaluation.Visual evaluation of the returned sample showed the catheter to be stretched and sheared in half approximately three (3) inches from the connector.Although the returned catheter was damaged, stretched and torn in half, since it had been opened and used, it is not believed to be the result of any manufacturing process.Per the manufacturer's investigation this defect is not likely to have happened during the manufacturing process.It is believed to have happened during application.Per the instructions for use (ifu): warnings: do not apply excessive force during needle advancement.Do not utilize needle if it bends or tip becomes damaged.Needle with damaged tip increases the risk of intrathecal or intravascular placement.If resistance is felt during advancement of the needle, carefully correct the orientation of the needle but never apply excessive force.Caution: do not withdraw catheter through the needle because of the possible danger of shearing or kinking.If the catheter becomes difficult to withdraw, consult standard textbooks for specific techniques.If additional pertinent information becomes available a follow-up report will be filed.

• Brand Name: DESIGN OPTIONS®
• Common Device Name: EPIDURAL ANESTHESIA KIT
• MDR Report Key: 12304009
• Report Number: 2523676-2021-00248
• Device Sequence Number: 17136493
• Product Code: OGE
• UDI-Device Identifier: 04046955589463
• UDI-Public: 04046955589463
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2021

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 Model Number: 552175
• Device Catalogue Number: 552175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2021
• Initial Date Received by Manufacturer: 08/02/2021
• Supplement Date Received by Manufacturer: 08/02/2021
• Initial Report FDA Received Date: 08/10/2021
• Supplement Report FDA Received Date: 09/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 31 YR