MAUDE Adverse Event Report: PAJUNK MEDICAL SYSYTEMS, LP TAL101; EPIDURAL ANESTHESIA KIT

Model Number	TAL101
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The needle in the convenience kit has been supplied in bulk, non-sterile by the needle manufacturer.The complaint was forwarded to the manufacturer for investigation.The device has not been returned for analysis and limited data is currently available.
Event or Problem Description
On (b)(6) 2019 after placing the epidural catheter in a laboring patient, the anesthesiologist was withdrawing the tuohy needle (item code (b)(4)) slowly with no unusual resisitance when the plastic part of the end of the needle broke off.The doctor states he was not pulling hard on the needle.The needle was packaged in an epidural convenience kit, item code (b)(4).The anesthesiologist was not able to provide the lot number of the kit that was used.The procedure was for the most part complete and the patient was not affected in any way.

• Brand Name: TAL101
• Common Device Name: EPIDURAL ANESTHESIA KIT
• Manufacturer (Section D): PAJUNK MEDICAL SYSYTEMS, LP; 6611 bay circle ste. 140; norcross GA 30071
• MDR Report Key: 9171711
• Report Number: 3004076349-2019-00004
• Device Sequence Number: 2055435
• Product Code: OGE
• UDI-Device Identifier: 00858965006007
• UDI-Public: (01)00858965006007
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/09/2019

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 Model Number: TAL101
• Device Catalogue Number: TAL101
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2019
• Initial Report FDA Received Date: 10/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 16 YR
• Patient Weight: 91