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

Model Number	TAL101
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of device is in-progress.
Event or Problem Description
On (b)(6) 2019, pajunk received a complaint report on the epilong soft tray 17g x 103mm needle in the tal101 epidural anesthesia kit.The red cap on the plastic stylet came off the stylet when being pulled out of the needle causing the stylet to get stuck in the needle.This occurred 6 times in over 2 weeks.No patients suffered injury due to this incident.

• 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: 8833699
• Report Number: 3004076349-2019-00003
• Device Sequence Number: 14081891
• Product Code: OGE
• UDI-Device Identifier: 00858965006007
• UDI-Public: (01)00858965006007(17)200430(10)0000225
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 07/26/2019

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 Expiration Date: 04/30/2020
• Device Model Number: TAL101
• Device Catalogue Number: TAL101
• Device Lot Number: 0000225
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2019
• Initial Report FDA Received Date: 07/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1