MAUDE Adverse Event Report: BECTON DICKINSON HUNGARY KFT (BD) ULTRASAFE B100L NG GREEN BULK AMG

Catalog Number 47436630

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/05/2021

Event Type  malfunction  

Manufacturer Narrative

Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 9167936, medical device expiration date: 2023-05-31, device manufacture date: 2019-06-16.Medical device lot #: 9199431, medical device expiration date: 2023-06-30, device manufacture date: 2019-07-18.Medical device lot #: 0191620, medical device expiration date: 2024-06-30, device manufacture date: 2020-07-09.Investigation summary: the customer issued a complaint for separated product detected by end user.No sample was provided to bdm-ps for analysis; therefore, it is not possible to investigate the reported condition.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 met all acceptable quality levels (aql¿s), were manufactured and released according to applicable procedures and specifications.This product 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 a syringe can only become detached if syringe capture features (holding clips) of the device or the flange of the syringe get damaged/broken or the syringe receives an impact after syringe insertion which causes it to unclip from the device.Therefore, the syringe most likely became detached as it received an external impact after syringe insertion.None of these causes are related to bd process.

Event Description

It was reported that ultrasafe b100l ng green bulk amg safety device detached.The following information was provided by the initial reporter: the needle guard from one prolia pfs detached in preparation to administer the dose.

• Brand Name: ULTRASAFE B100L NG GREEN BULK AMG
• Type of Device: ULTRASAFE
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12236172
• MDR Text Key: 264985802
• Report Number: 3009081593-2021-00034
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 47436630
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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