MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SPROTTE; SPINAL NEEDLE ANAESTHESIA CONDUCTION

Model Number	041151-30A
Medical Device Problem Codes	Break (1069); Fracture (1260); Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682); Device Handling Problem (3265)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(4).Date of event unknown.Took place in (b)(6) and has been reported to tga.From initial reporter¿s narrative: doctor was unaware needle had broken off, so can't comment on whether occurred on insertion or removal 4 attempts at lp, 3 needles used - 24g x 3 broken-off fragment was found when patient returned as an outpatient to have a fluoroscopic-guided lp 5 days later- it was seen on the scout film.The patient was then admitted through ed and had the 65mm fragment removed by the neurosurgery team 6 days after the initial lp.On the day of discharge from hospital there had been no adverse outcome recorded, aside from surgery (no neurological deficit, no infection) the hospital report is not finalised.
Additional Manufacturer Narrative
Based on risk assessment and clinical evaluation file is considered as closed.
Event or Problem Description
Irn# (b)(4).Date of event still unknown.Took place in (b)(6) and has been reported to tga.From initial reporter¿s narrative: doctor was unaware needle had broken off, so can't comment on whether occurred on insertion or removal 4 attempts at lp, 3 needles used - 24g x 3 broken-off fragment was found when patient returned as an outpatient to have a fluoroscopic-guided lp 5 days later- it was seen on the scout film.The patient was then admitted through ed and had the 65mm fragment removed by the neurosurgery team 6 days after the initial lp.On the day of discharge from hospital there had been no adverse outcome recorded, aside from surgery (no neurological deficit, no infection) the hospital report is not finalised.

• Brand Name: SPROTTE
• Common Device Name: SPINAL NEEDLE ANAESTHESIA CONDUCTION
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; geisingen, baden-wuerttemberg 78187 ; GM 78187
• MDR Report Key: 7005450
• Report Number: 9611612-2017-00013
• Device Sequence Number: 1228603
• Product Code: BSP
• UDI-Device Identifier: 14048223000516
• UDI-Public: 14048223000516
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K911202
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2017

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: Physician
• Device Expiration Date: 05/08/2022
• Device Model Number: 041151-30A
• Device Catalogue Number: 041151-30A
• Device Lot Number: 1205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/27/2017
• Supplement Date Received by Manufacturer: 10/27/2017
• Initial Report FDA Received Date: 11/07/2017
• Supplement Report FDA Received Date: 12/05/2017
• 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: Other