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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD SYRINGE PISTON SYRINGE

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BECTON DICKINSON UNSPECIFIED BD SYRINGE PISTON SYRINGE Back to Search Results
Catalog Number UNKNOWN
Device Problem Missing Information (4053)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/10/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Unknown manufacturer: (b)(4). The customer's address is unknown. (b)(6) has been used as a default. Medical device expiration date: unknown. Medical device manufacture date: unknown. Investigation summary: exec summary: no samples were returned therefore bd was not able to duplicate or confirm the customers indicated failure and the root cause is undetermined. Unable to perform complaint lot history check owing to an unknown lot number for this event. Capa/sa: based on the above no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) are required at this time. Dhr review: no dhr review can be carried out as the lot number is unknown.
 
Event Description
It was reported that 1 unspecified bd" syringe had a label information issue. The following information was provided by the initial reporter: it was reported that there was no expiration date. Date of event: unknown. Samples: no.
 
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Brand NameUNSPECIFIED BD SYRINGE
Type of DevicePISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer (Section G)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12439588
MDR Text Key270351800
Report Number2243072-2021-02259
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,other
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/25/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/10/2021
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

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