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

Model Number 041151-30A

Device Problems Break (1069); Fracture (1260); Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682); Device Handling Problem (3265)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Event 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.

Manufacturer Narrative

Based on risk assessment and clinical evaluation file is considered as closed.

Event 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
• Type of Device: SPINAL NEEDLE ANAESTHESIA CONDUCTION
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; geisingen, baden-wuerttemberg 78187 ; GM 78187
• Manufacturer (Section G): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; geisingen, baden-wuerttemberg 78187 ; GM 78187
• Manufacturer Contact: christian quass ; karl-hall-str. 1; geisingen, baden-wuerttemberg 78187 ; GM 78187
• MDR Report Key: 7005450
• MDR Text Key: 92481030
• Report Number: 9611612-2017-00013
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 14048223000516
• UDI-Public: 14048223000516
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K911202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other