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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO BD SYRINGE WITH ULTRA-FINE¿ NEEDLE; SYRINGE WITH NEEDLE

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BECTON DICKINSON DE MEXICO BD SYRINGE WITH ULTRA-FINE¿ NEEDLE; SYRINGE WITH NEEDLE Back to Search Results
Catalog Number 326786
Device Problem Material Separation (1562)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/16/2018
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).Investigation summary: customer returned photos of a 1/2cc syringe.Customer states that the plunger is detached from the rubber stopper and it remains inside the barrel of the syringe.The attached photos were examined and exhibited the stopper separated from the plunger rod.A review of the device history record was completed for batch# 7352815.All inspections and challenges were performed per the applicable operations qc specifications.There were two (2) notifications [(b)(4)] noted that did not pertain to the complaint.Investigation conclusion: confirmed: bd was able to duplicate or confirm the customer¿s indicated failure root cause description: insufficient silicone in the barrel.
 
Event Description
It was reported that rubber stopper on a bd syringe with ultra-fine¿ needle separated from the plunger rod.There was no report of exposure, serious injury, or medical intervention.
 
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Brand Name
BD SYRINGE WITH ULTRA-FINE¿ NEEDLE
Type of Device
SYRINGE WITH NEEDLE
Manufacturer (Section D)
BECTON DICKINSON DE MEXICO
autopista
55 59 99 8400, k.m. 37.5
cuautitlan izcalli
Manufacturer (Section G)
BECTON DICKINSON DE MEXICO
autopista
55 59 99 8400, k.m. 37.5
cuautitlan izcalli
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key8043375
MDR Text Key128257527
Report Number9614033-2018-00083
Device Sequence Number1
Product Code FMF
UDI-Device Identifier00382903267866
UDI-Public382903267866
Combination Product (y/n)N
Reporter Country CodeMX
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 11/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date01/31/2023
Device Catalogue Number326786
Device Lot Number7352815
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/16/2018
Initial Date FDA Received11/06/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/30/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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