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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD SYRINGE
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BECTON DICKINSON UNSPECIFIED BD SYRINGE Back to Search Results
Catalog Number UNKNOWN
Device Problems Inappropriate Audible Prompt/Feedback (2280); Device Displays Incorrect Message (2591)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/23/2021
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.Medical device expiration date: unknown.The customer's address is unknown.New jersey (nj), usa has been used as a default.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
 
Event Description
It was reported that unspecified bd¿ syringe pump alarm went off.The following information was provided by the initial reporter: it was reported that the syringe pump with lipids displayed incorrect available volume than what was actually in the syringe.Verbatim: it was reported that the syringe pump with lipids displayed incorrect available volume than what was actually in the syringe.An infant received lipids at 1.4 ml/hr.30 ml syringe was hung at about 0500 on 2/23.Syringe alarm near empty at about 0930.Volume available displayed 2 ml but about 20 ml actual in syringe.Nurse removed and replaced syringe and correct available volume than displayed.After reviewing logs, it appears that the syringe module identified the syringe as a 30 ml bd with only 6.2982.There was no harm or adverse effect on the patient.
 
Manufacturer Narrative
The following fields have been updated with additional information: g.4.Date received by manufacturer: 2021-03-09.H.6.Investigation summary: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Capa is not required at this time.
 
Event Description
It was reported that unspecified bd¿ syringe pump alarm went off.The following information was provided by the initial reporter: it was reported that the syringe pump with lipids displayed incorrect available volume than what was actually in the syringe.Verbatim: it was reported that the syringe pump with lipids displayed incorrect available volume than what was actually in the syringe.An infant received lipids at 1.4 ml/hr.30 ml syringe was hung at about 0500 on 2/23.Syringe alarm near empty at about 0930.Volume available displayed 2 ml but about 20 ml actual in syringe.Nurse removed and replaced syringe and correct available volume than displayed.After reviewing logs, it appears that the syringe module identified the syringe as a 30 ml bd with only 6.2982.There was no harm or adverse effect on the patient.
 
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Brand Name
UNSPECIFIED BD SYRINGE
Type of Device
SYRINGE
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key12178777
MDR Text Key261906181
Report Number2243072-2021-01887
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 07/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
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
Initial Date Manufacturer Received 06/21/2021
Initial Date FDA Received07/15/2021
Supplement Dates Manufacturer Received03/09/2021
Supplement Dates FDA Received07/20/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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