MAUDE Adverse Event Report: BECTON DICKINSON HUNGARY KFT (BD) BD ULTRASAFE PASSIVE¿ X-SERIES NEEDLE GUARD SYRINGE - X100L; PISTON SYRINGE

Catalog Number 47450030

Device Problems Detachment Of Device Component (1104); Fail-Safe Design Failure (1222); Retraction Problem (1536)

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

Event Date 06/03/2016

Event Type  malfunction  

Manufacturer Narrative

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 for the reported lot # 0312133 revealed that the batch was produced by ssi in carlsbad.Four events of non-activation issues were discovered during production of this batch.Three of the failures occurred during activation cycle testing.The failures were in a fully locked out condition when evaluated by engineering.The components had no obvious damage, bends, marks or surface contamination that might have contributed to an activation cycle test failure on the zwick test station.It was determined that the zwick software did not properly calculate/identify the correct maximum and minimum force prior to lockout.The fourth non-activation issue also occurred during activation cycle testing but showed that one trigger finger was still attached, preventing the assembly from activating and it appeared the test equipment did not fully trigger the assembly.The device was activated manually which resulted in the assembly fully activating and achieving lock out.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.Capa (b)(4) was opened for the zwick software issue that did not properly calculate/identify the correct maximum and minimum force prior to lockout.The issue was solved by modifying software configurations for peak detection.Capa (b)(4) was opened for the zwick tester.Engineering determined that the head fixture travel distance of the zwick tester was insufficient for consistent activation of devices during the activation cycle test.Engineering has properly adjusted the head fixture position and secured it.All of these issues reported were identified as measuring equipment issues and not a device issue.(b)(4).

Event Description

It was reported that after injecting himself with a medication with a bd ultrasafe passive¿ x-series needle guard syringe - x100l, the safety mechanism failed to function properly.The needle did not retract immediately and the plunger separated from the syringe after the delayed retraction.There was no report of injury or medical intervention.

• Brand Name: BD ULTRASAFE PASSIVE¿ X-SERIES NEEDLE GUARD SYRINGE - X100L
• 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: 6332222
• MDR Text Key: 67839693
• Report Number: 3009081593-2017-00002
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: ?
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2017
• Device Catalogue Number: 47450030
• Device Lot Number: 312133
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other