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U.S. Department of Health and Human Services


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Catalog Number UNKNOWN
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/31/2021
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 device manufacture date: unknown investigation summary: as no physical sample, material and/or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed. Based on the limited investigation results, a cause for the reported incident could not be determined. Examination of the product involved may provide clarification as to the cause for the reported failure. Complaints received for this device and reported condition will continue to be tracked and trended. Our quality team regularly reviews the collected data for identification of emerging trends. Investigation conclusion: material number and batch number is unknown; reviews could not be performed. Based on limited information available after multiple unsuccessful attempts to obtain - unable to assess the rm documentation. No physical sample was provided by the customer.   capa is not required at this time.
Event Description
It was reported that the unspecified bd syringe experienced a plunger that was loose/fell out. The following information was provided by the initial reporter: when the cannula was to be attached, it was discovered that the piston was loose. When the nurse screws it on, the glass syringe comes loose completely and falls to the floor. Left in the hand are the needle and plunger.
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Type of DeviceSYRINGE
Manufacturer (Section D)
1 becton drive
franklin lakes NJ 07417
Manufacturer (Section G)
1 becton drive
franklin lakes NJ 07417
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
MDR Report Key12076824
MDR Text Key258708661
Report Number2243072-2021-01762
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
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,Followup
Report Date 07/02/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/28/2021
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 Received06/17/2021
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