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

Model Number 121251-27A

Device Problems Break (1069); Crack (1135); Fracture (1260); Inadequacy of Device Shape and/or Size (1583); Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Inadequate Pain Relief (2388); Foreign Body In Patient (2687)

Event Date 09/30/2016

Event Type  malfunction  

Manufacturer Narrative

Event took place in the (b)(6) and has been reported through (b)(4) distribution subsidiary pajunk medical (b)(4).Currently the data is poor and the device has not been sent back/ analysed.As soon as further data will be available a follow up report will be sent in to the agency.

Event Description

(b)(4).Summarizing tentative translation from initial reporter's narrative: needle broke within patient upon spinal anaesthesia.Neurological evaluation: leave fragment with patient.

Manufacturer Narrative

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

Event Description

(b)(4).Summarizing tentative translation from initial reporter´s narrative: needle broke within patient upon spinal anaesthesia.Neurological evaluation: leave fragment with patient.Patient is quite voluminous.Difficult approach.

• Brand Name: SPROTTE
• Type of Device: SPINAL REGIONAL BLOCK ANAESTHESIA CONDUCTION NEEDLE
• 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; regulatory & safety affairs; geisingen, baden-wuerttemberg 78187 ; GM 78187 ; 7704929158
• MDR Report Key: 6059529
• MDR Text Key: 58455853
• Report Number: 9611612-2016-00140
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 14048223022808
• UDI-Public: 14048223022808
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K911202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/28/2016

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
• Device Operator: Physician
• Device Expiration Date: 03/01/2021
• Device Model Number: 121251-27A
• Device Catalogue Number: 121251-27A
• Device Lot Number: 1152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/04/2016
• Initial Date FDA Received: 10/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2016
• 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; Required Intervention
• Patient Weight: 105