MAUDE Adverse Event Report: BECTON DICKINSON HUNGARY KFT (BD) BD ULTRASAFE B100L NG GREEN; PISTON SYRINGE

Catalog Number 47436630

Device Problems Break (1069); Difficult or Delayed Activation (2577)

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

Event Date 12/09/2019

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone #: unknown.Initial reporter state: address information was not able to be obtained.(b)(6).Investigation summary: the customer issued a complaint for a damaged/defective needle guard detected by end user.Neither sample nor photo 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 batches involved in this complaint meet all acceptable quality levels (aql¿s), were manufactured and released according to applicable procedures and specifications.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.Root cause description: complaint is unconfirmed.

Event Description

It was reported that during use the safety device separated, and syringe fell to ground with a bd ultrasafe¿ b100l ng green.The following information was provided by the initial reporter: complainant reported that was holding the green needle safety cover, and while doing so she went to pull the needle cap off of the needle, and then the syringe fell out of the green needle safety cover, and afterwards she was still holding only the green needle safety cover while the syringe fell to the floor.No medication leaked out of the syringe since the nurse never got the needle cap off of the needle itself.Nurse states that the needle cap is still on the needle and the syringe is still full of medication.

• Brand Name: BD ULTRASAFE B100L NG GREEN
• 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 ; 8015652341
• MDR Report Key: 9527942
• MDR Text Key: 213713783
• Report Number: 3009081593-2019-00280
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972878
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: 47436630
• Device Lot Number: 9077505
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2019
• 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