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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD SYRINGE/NEEDLE

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BECTON DICKINSON UNSPECIFIED BD SYRINGE/NEEDLE Back to Search Results
Catalog Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 05/18/2019
Event Type  Injury  
Manufacturer Narrative
There are multiple bd locations where this unspecified bd device may have been manufactured. A catalog or a lot number could not be confirmed for this incident, and without this information we are unable to determine where the device was manufactured. Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number. Device expiration date: unknown. Device manufacture date: unknown. The customer's address is unknown:  (b)(6), usa has been used as a default.  fda notified: the initial reporter also notified the fda on (06/05/2019) via medwatch # mw5086968. Investigation summary: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided. Investigation conclusion: bd was not able to duplicate or confirm the customer¿s indicated failure as no sample, batch, or lot code was provided. This complaint will be entered into the complaint management system and will be tracked & trended for future occurrences. Root cause description: root cause is undetermined.
 
Event Description
It was reported that a serious injury occurred with a unspecified bd syringe/needle. The following information was provided by the initial reporter, "patient has an infection and has been prescribed an antibiotic infusion for it. Dates of use: 1 year. " no additional information has been reported.
 
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Brand NameUNSPECIFIED BD SYRINGE/NEEDLE
Type of DeviceSYRINGE
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
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key8735857
MDR Text Key149241669
Report Number2243072-2019-01271
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 health professional,other
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 06/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/26/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
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 Received06/10/2019
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 Treatment Data
Date Received: 06/26/2019 Patient Sequence Number: 1
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