MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SPROTTE; SPINAL NEEDLE, SINGLE USE

Model Number	121151-30A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter´s health care facility report number: (b)(6).Currently the information supplied would allow closure of the case since the complication seems to be a procedure related typical complication.In case the device is returned, it will be analysed.In case of analyses an additional report will be sent in to the agency.
Event or Problem Description
Irn# (b)(4).Initial reporter´s narrative/ information provided in initial reporters report # (b)(6).Pt sitting up for spinal anesthesia being performed and a portion of the spinal needle broke off inside of the patient.Ls ct confirmed retained spinal needle.Removal in or uneventfully of bent spinal needle w7 post op imaging confirming no rfo.

• Brand Name: SPROTTE
• Common Device Name: SPINAL NEEDLE, SINGLE USE
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str. 7; geisingen, 78187 ; GM 78187
• Manufacturer (Section G): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str. 7; geisingen, 78187 ; GM 78187
• Manufacturer Contact: christian quass ; karl-hall-str. 1; tuttlinger str. 7; geisingen, 78187 ; GM 78187
• MDR Report Key: 13288393
• Report Number: 9611612-2022-00002
• Device Sequence Number: 4280993
• Product Code: BSP
• UDI-Device Identifier: 04048223107119
• UDI-Public: 04048223107119
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K911202
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 01/19/2022

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 Expiration Date: 01/25/2026
• Device Model Number: 121151-30A
• Device Catalogue Number: 121151-30A
• Device Lot Number: 1382
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2022
• Initial Report FDA Received Date: 01/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 26 YR
• Patient Sex: Female
• Patient Weight: 123 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American