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

Catalog Number 47435830

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 03/01/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that during use a bd safetyglide¿ needle malfunctioned as ¿this needle was used on a patient ¿ i left needle guard on as it was received.(not locked in place).¿ there was no report of exposure, injury or medical intervention needed.

Manufacturer Narrative

Neither photo nor sample was provided to bd medical ¿ pharmaceutical system (bdm-ps) for analysis.Bdm-ps performed a batch history record¿s review (bhr) including a review of all data collected during in process and quality inspections.The batch involved in this complaint meets all acceptable quality levels (aqls), was manufactured and released according to applicable procedures and specifications.Based on the investigation conclusion, bdm-ps was not able to confirm the symptom perceived by the customer or correlate this symptom with a potential cause linked to bd process.

• Brand Name: BD ULTRASAFE¿ INJECTION SYSTEM NEEDLE GUARD (B-SERIES)
• 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: 7331030
• MDR Text Key: 102207556
• Report Number: 3009081593-2018-00018
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K972878
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/13/2018

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 Expiration Date: 02/29/2020
• Device Catalogue Number: 47435830
• Device Lot Number: 6060087
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/01/2018
• Initial Date FDA Received: 03/12/2018
• Supplement Dates Manufacturer Received: 03/01/2018
• Supplement Dates FDA Received: 04/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/29/2016
• 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