MAUDE Adverse Event Report: BECTON DICKINSON HUNGARY KFT (BD) BD ULTRASAFE PASSIVE¿ X-SERIES NEEDLE GUARD SYRINGE; PISTON SYRINGE

Catalog Number 47439230

Device Problem Fail-Safe Design Failure (1222)

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

Event Date 10/03/2016

Event Type  malfunction  

Manufacturer Narrative

The date received by manufacturer has been used for date of event.Results: a sample is not available for evaluation.As part of a no sample investigation, 25 retention samples were evaluated for safety mechanism failure; 10 units were tested by activation cycle and 15 units were tested by manual triggering.All samples passed testing, reached lock-out position after activation, and did not show any safety device issues.A review of the device history record revealed no irregularities or non-conformances during the manufacture of the reported lot # 5239129.A manufacturing process review showed no issues with spring formation, device assembly, packaging, raw material incoming inspection, in process inspection (100% automated primary function test, controlled trigger test, activation cycle test), or final inspection.Conclusion: without a sample, an absolute root cause for this incident cannot be determined.No issues were observed with retention sample testing or found within the device history record and manufacturing process reviews.(b)(4).

Event Description

It was reported that the safety mechanism of a bd ultrasafe passive x-series needle guard syringe did not work and a needle was left uncovered post use.No serious injury or medical interventions were reported.

• Brand Name: BD ULTRASAFE PASSIVE¿ X-SERIES NEEDLE GUARD SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON HUNGARY KFT (BD); uveggyar utca 3; kornye tatabanya 2851 ; HU 2851
• Manufacturer (Section G): BECTON DICKINSON HUNGARY KFT (BD); uveggyar utca 3; kornye tatabanya 2851 ; HU 2851
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 6021525
• MDR Text Key: 57585786
• Report Number: 3009081593-2016-00002
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K011369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: 47439230
• Device Lot Number: 5239129
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2016
• 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