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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD SAFETYGLIDE SYRINGE

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BECTON DICKINSON UNSPECIFIED BD SAFETYGLIDE SYRINGE Back to Search Results
Catalog Number UNKNOWN
Device Problems Leak/Splash (1354); Packaging Problem (3007)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/11/2021
Event Type  malfunction  
Manufacturer Narrative
Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured. A catalog and 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. Date of event: unknown. The date received by manufacturer has been used for this field. Device expiration date: unknown. Initial reporter phone #: an additional phone # was provided as (b)(6). Device manufacture date: unknown investigation summary: as the material and lot numbers were unknown for this incident and samples were unavailable for return, a complete investigation could not be performed. Based on the limited investigation results, a cause for the reported incident could not be determined. Complaints received will continue to be tracked and trended. Our quality team regularly reviews the collected data for identification of emerging trends.
 
Event Description
It was reported that unspecified bd safetyglide syringe experienced 2 cases of leakage, and 1 case of damaged or open unit packaging/seal where sterility was compromised. The following information was provided by the initial reporter: material no: unknown batch no: unknown it was reported via survey response that the clinician experienced leakage (2), needlestick injury before use on patient (2), syringe needle connectivity issue (3), package open before use (1). Additional information related to what leaked and from where: "saline solution. Intravenous antibiotic. " "connection point between the tubing and the needle. ".
 
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Brand NameUNSPECIFIED BD SAFETYGLIDE SYRINGE
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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key11645937
MDR Text Key245855513
Report Number2243072-2021-01055
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
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 Received03/11/2021
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

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