MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SPROTTE; 868.5150 ANETHESIA CONDUCTION NEEDLE

Model Number 021251-29A

Device Problem Insufficient Information (3190)

Patient Problems Headache (1880); Complaint, Ill-Defined (2331)

Event Date 04/11/2014

Event Type  Injury  

Event Description

(b)(4).Event took place in (b)(4) and has been reported to (b)(4).Description of the customer: "the patient suffered a post dural puncture headache secondary to multiple attempts that presumably punctured the dura but resulted in no csf flow back to the hub".

Manufacturer Narrative

No specific corrective action due to mitigative prevention of hazards is assigned to this report.A review of the relevant records and the raw material files of the affected batch did neither indicate recorded quality problems nor rejections related to this incident.The complaint is deemed to be a user error in handling.If any further information is becoming available, mfr will immediately inform fda.If no further information is becoming available, mfr considers this file as closed.

• Brand Name: SPROTTE
• Type of Device: 868.5150 ANETHESIA CONDUCTION NEEDLE
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-strasse 01; geisingen, baden-wurttemberg 7818 7; GM 78187
• Manufacturer Contact: christian quass ; karl-hall-strasse 01; geisingen, baden-wurttemberg ; GM ; 7049291586
• MDR Report Key: 3987650
• MDR Text Key: 4749332
• Report Number: 9611612-2014-00013
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• PMA/PMN Number: K911260
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Type of Report: Initial
• Report Date: 07/23/2014

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?: No
• Device Operator: Other
• Device Expiration Date: 11/01/2013
• Device Model Number: 021251-29A
• Device Lot Number: 1042
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/21/2014
• Initial Date FDA Received: 07/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention