MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD SPINAL NEEDLE

Catalog Number 405259

Device Problems Difficult to Remove (1528); Device Operates Differently Than Expected (2913)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 11/21/2017

Event Type  Injury  

Manufacturer Narrative

Medical device expiration date: unknown.The reported lot # does not exist for the reported cat #.Therefore, the device manufacture and expiration dates are unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that during use, a bd spinal needle malfunctioned as a lumbar puncture was performed.¿the stiletto was removed and did not come out¿.This resulted in spinal fluid leakage.Although this is a serious injury, there was no report of injury or medical intervention reported.

Manufacturer Narrative

The sample received is bent, therefore the stiletto cannot be removed properly.It is not possible to know when the needle was bent: it could be bent during packaging process but also during its use.If during insertion, the needle was bent, the stiletto can be damaged.If the packaging was not carefully opened, the spinal needle can also be damaged during that step.No quality notifications or other events have been found during device history record review.Two retained samples have been checked and no defects were found.During assembly process, several inspections are carried out according to internal procedures to avoid defects in spinal needles.It is checked that the stiletto is easy to remove from the cannula and that the spinal needle has no defects (nicks, particles, etc).Visual inspection of the units is also performed during packaging and packing process.Conclusion: no root cause can be determined.Based on the low severity and frequency of the defect it was determined that no capa is required.

• Brand Name: BD SPINAL NEEDLE
• Type of Device: SPINAL NEEDLE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7113207
• MDR Text Key: 94727013
• Report Number: 3003152976-2017-00178
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/10/2018

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: Other
• Device Catalogue Number: 405259
• Device Lot Number: 1617002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/21/2017
• Initial Date FDA Received: 12/13/2017
• Supplement Dates Manufacturer Received: 11/21/2017
• Supplement Dates FDA Received: 01/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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