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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD PREFILLED SYRINGE; SALINE, VASCULAR ACCESS FLUSH
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BECTON DICKINSON UNSPECIFIED BD PREFILLED SYRINGE; SALINE, VASCULAR ACCESS FLUSH Back to Search Results
Catalog Number UNKNOWN
Device Problems Break (1069); Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/27/2022
Event Type  malfunction  
Event Description
It was reported while using an unspecified bd prefilled syringe the barrel was damaged and leaked.There was no report of patient impact.The following information was provided by the initial reporter: dinoprostone pre-filled infusion syringe was found to be cracked along the side of the syringe (underneath the label sticker) and leaking onto the floor.
 
Manufacturer Narrative
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 in and the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
 
Manufacturer Narrative
H6: investigation summary as no physical sample, valid part number 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.A device history review could not be completed as no batch number was provided.
 
Event Description
It was reported while using an unspecified bd prefilled syringe the barrel was damaged and leaked.There was no report of patient impact.The following information was provided by the initial reporter: dinoprostone pre-filled infusion syringe was found to be cracked along the side of the syringe (underneath the label sticker) and leaking onto the floor.
 
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Brand Name
UNSPECIFIED BD PREFILLED SYRINGE
Type of Device
SALINE, VASCULAR ACCESS FLUSH
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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key15756480
MDR Text Key307285605
Report Number2243072-2022-01907
Device Sequence Number1
Product Code NGT
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Consumer
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2022
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
Date Manufacturer Received11/14/2022
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 Sequence Number1
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