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

Catalog Number 47436230

Device Problems Premature Activation (1484); Failure to Deliver (2338)

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

Event Date 10/01/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used.Medical device expiration date: unknown.Initial reporter phone #: unknown.Device manufacture date: unknown.Investigation conclusion: the customer issued a complaint for defective needle guard detected by end user.Neither sample nor photo was provided to bd medical - pharmaceutical system (bdm-ps) for analysis.Batch is unknown.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.Root cause description: based on the investigation conclusion the defect occurred due to misuse of the combination product.Rationale: complaint is unconfirmed.

Event Description

It was reported that the pen pre-activated with an bd ultrasafe b100l ng yellow.The following information was provided by the initial reporter: pharmacy tech called and stated that she had a patient who had the aranesp "autoinjector" (later clarified with intake agent as pfs) and it "retracted" but the patient did not use it.

• Brand Name: BD ULTRASAFE B100L NG YELLOW
• Type of Device: ANTISTICK 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: 9218447
• MDR Text Key: 216635691
• Report Number: 3009081593-2019-00235
• Device Sequence Number: 1
• Product Code: MEG
• 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: consumer,distributor,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 47436230
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/01/2019
• 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
• Patient Outcome(s): Other