MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD YALE¿ QUINCKE POINT SPINAL NEEDLE WITHOUT INTRODUCER 20 G X 3 1/2 IN.

Catalog Number 405253

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/02/2015

Event Type  Injury  

Manufacturer Narrative

(b)(6).Pma / 510(k) #: there is no 510(k) for this device as it is manufactured outside the us and not sold in the us.A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: february, 2015.

Event Description

It was reported that the tip of a bd yale quincke point spinal needle without introducer 20 g x 3 1/2 in.Broke off as it was being removed and remained in the patient's soft tissue.The patient had surgery to remove a needle.No medications were provided because of this incident and no other medical interventions were necessary.

Manufacturer Narrative

Results: one used sample was returned for evaluation.A visual/microscopic inspection revealed the tip of the needle was missing and the damaged part of the needle is curved.This kind of damage is produced in case that needle has had to be redirected to a new position.The defect was reproduced in the quality lab using new spinal needle of the same gauge.The needle was introduced in a soft material and after removing no damages were produced.The 20ga is one of the largest diameter cannulas and can't easily be bent.A pull force test was performed on the sample and on four retention samples with no abnormalities observed.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 1502006.Conclusion: an absolute root cause for this incident cannot be determined.However, our quality engineer notes that the most probable root cause is that the user made contact with hard tissue or bone, bent the needle, and continued to use it until it broke.

• Brand Name: BD YALE¿ QUINCKE POINT SPINAL NEEDLE WITHOUT INTRODUCER 20 G X 3 1/2 IN.
• 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: 5710632
• MDR Text Key: 47094830
• Report Number: 3003152976-2016-00007
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 06/16/2016

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: Health Professional
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 405253
• Device Lot Number: 1502006
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/01/2016
• Initial Date FDA Received: 06/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/16/2016
• 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): Required Intervention