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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD POSIFLUSH¿ PRE-FILLED HEPARIN LOCK FLUSH; SALINE VASCULAR ACCESS FLUSH

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BECTON DICKINSON UNSPECIFIED BD POSIFLUSH¿ PRE-FILLED HEPARIN LOCK FLUSH; SALINE VASCULAR ACCESS FLUSH Back to Search Results
Catalog Number UNKNOWN
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/01/2022
Event Type  malfunction  
Event Description
It was reported that an unspecified bd posiflush¿ pre-filled heparin lock flush leaked.The following information was provided by the initial reporter: "during the saline test it leaked.".
 
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)(6) has been listed in sections manufacturer name, city and state and mfr site and the franklin lakes fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: as no physical sample, valid part number or lot number was provided for evaluation, a complete investigation could not be performed.Based on the limited investigation results, a cause for the reported incident could not be determined.
 
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Brand Name
UNSPECIFIED BD POSIFLUSH¿ PRE-FILLED HEPARIN LOCK FLUSH
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 Key14860216
MDR Text Key301748022
Report Number2243072-2022-00878
Device Sequence Number1
Product Code NGT
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 Other,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2022
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 Received06/01/2022
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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