MAUDE Adverse Event Report: BECTON DICKINSON HUNGARY KFT (BD) BD ULTRASAFE¿ MANUAL NEEDLE GUARD; SYRINGE WITH NEEDLE

Catalog Number 47436030

Device Problem Fail-Safe Design Failure (1222)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/16/2018

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 and/or device history review, a supplemental report will be filed.

Event Description

It was reported that when opening the package containing a bd ultrasafe¿ manual needle guard, the syringe ¿fell out¿ of the safety mechanism, and left the device without a safety mechanism.There was no report of exposure, injury or medical intervention.

Manufacturer Narrative

A photo was received for inspection.Based on the photo no damage was observed on syringe capture features.The manual needle guard syringe flange holding clips were observed straight and properly aligned.The syringe is not in the photo so we cannot see any impact on the syringe flange.25 retain samples were inspected.All of them are within specification.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.Investigation conclusion: unconfirmed, no bd cause found.This device was designed with a low clipping force to accommodate easily all types of syringes during device assembly and so minimizing risk of flange or device breakage.The draw-back of this design is the relatively low retention force.Based on investigation conclusion the syringe most likely became detached as it was not clipped into the device or the product received an external impact after syringe insertion which caused the syringe to unclip from the device.

• Brand Name: BD ULTRASAFE¿ MANUAL NEEDLE GUARD
• Type of Device: SYRINGE WITH NEEDLE
• 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: 7394160
• MDR Text Key: 104414710
• Report Number: 3009081593-2018-00025
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 47436030
• Device Lot Number: 6031334
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2016
• 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