MAUDE Adverse Event Report: BECTON DICKINSON HUNGARY KFT (BD) BD ULTRASAFE PLUS¿ PASSIVE NEEDLE GUARD; PISTON SYRINGE

Catalog Number 47439730

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fever (1858)

Event Date 06/10/2022

Event Type  Injury  

Manufacturer Narrative

The initial reporter also notified the fda.Medwatch report # mw5110470.Investigation summary: the customer issued a complaint for pre-activated problem 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 did not perform a batch history record¿s review (bhr) as batch number of the device is unknown.Based on investigation conclusion, bdm-ps was not able to confirm the symptom perceived by customer or correlate this symptom with a potential cause linked to bd process.Based on investigation conclusion, bdm-ps was not able to confirm the symptom perceived by customer or correlate this symptom with a potential cause linked to bd process.During the years of investigation of complaints about pre-activated devices several root causes were discovered which were within the customer¿s sphere of influence.Best practices and guidelines were collected and summarized in 442.Cdfm.010.

Event Description

It was reported that prior to use the bd ultrasafe plus¿ was unusable resulting in a need for medial intervention.The following information was provided by the initial reporter: patient received ziextenzo from a mail order pharmacy.When medication box was opened, safety needle mechanism had been previously engaged, causing medication to be unusable, as needle could not be re-extended and medication cannot be administered after mechanism engaged.Patient diagnosed with malignancy, using ziextenzo for prevention of prolonged neutropenia.Patient admitted to the hospital 6 days later for fever and neutropenia.

• Brand Name: BD ULTRASAFE PLUS¿ PASSIVE NEEDLE GUARD
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15136637
• MDR Text Key: 296952132
• Report Number: 3009081593-2022-00004
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 47439730
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/01/2022
• 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): Hospitalization