MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SPROTTE 2.G; SPINAL ANAESTHESIA CONDUCTION NEEDLE

Model Number 121251-27A

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

Patient Problems Pain (1994); Inadequate Pain Relief (2388)

Event Date 01/12/2017

Event Type  Injury  

Manufacturer Narrative

Event took place in (b)(6) and has been reported through (b)(4).Based on risk assessment and clinical evaluation, file is considered as closed.

Event Description

(b)(4).Tentative summarizing translation of initial reporter´s narrative: upon removal of spinal needle after unsuccessful spinal anaesthesia, 40mm of the distal end of the needle broke off.Must have been broken while placing the needle.Fragment has been retrieved the next day during surgical procedure.

• Brand Name: SPROTTE 2.G
• Type of Device: SPINAL 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: 6321530
• MDR Text Key: 67090011
• Report Number: 9611612-2017-00001
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 04048223022801
• UDI-Public: 04048223022801
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K911202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 10/01/2019
• Device Model Number: 121251-27A
• Device Catalogue Number: 121251-27A
• Device Lot Number: 1089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2014
• 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): Required Intervention
• Patient Age: 43 YR
• Patient Weight: 120