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

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/25/2014

Event Type  Injury  

Event Description

(b)(4).Event took place in (b)(6) and has been reported to (b)(4).Description of the customer: needle broke within patient after diagnostic lumbar puncture, required surgical intervention to retrieve fragment.

Manufacturer Narrative

No specific corrective action due to mitigative prevention of hazards is assigned to this report.A randomized review of the relevant records and the raw material files of the mfg batches did neither indicate recorded quality problems nor refections related to this incident.This info is being submitted to comply with the requirements of 21 cfr 803.The info in this report is not an admission that this device or any other device distributed by (b)(4) is or was defective or dangerous in any way, or caused or contributed to any pt injury.If any further info is becoming available, mfr immediately will inform fda.If no further info becomes available, mfr considers this file to be closed.

• Brand Name: SPROTTE
• Type of Device: 868.5150 ANESTHESIA 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 78187 ; GM 78187 ; 7049291586
• MDR Report Key: 4109147
• MDR Text Key: 4700575
• Report Number: 9611612-2014-00015
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/08/2014

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/03/2014
• Initial Date FDA Received: 09/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR