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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 Problem Inappropriate Audible Prompt/Feedback (2280)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/05/2021
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.(b)(6) usa has been used as a default.Device manufacture date: unknown.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 a clinician noted the pca syringe near empty, with a second clinician present.During clearing of pump history, the clinician noted the amount administered per pump did not match what amount would have been for the empty syringe.Verbatim: it was reported that a clinician noted the pca syringe near empty, with a second clinician present.During clearing of pump history, the clinician noted the amount administered per pump did not match what amount would have been for the empty syringe.The syringe in question was administered at 2034 on (b)(6) 2021 and was 50mg/50ml bd syringe dilaudid infusion.At the time of syringe change at 0645 on (b)(6) 2021, the syringe was empty, which would mean 50mg administered.Despite syringe being empty, the pump history read only 35.71mg was administered.The clinician called pharmacy and verified tubing was not changed and no priming had occurred.The patient was receiving high doses of medication and concentration of dilaudid 1mg/1ml was used.It was further noted that patient and family had silenced or restarted pumps and were educated not to manage device.There were no adverse effects caused to the patient.
 
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 a clinician noted the pca syringe near empty, with a second clinician present.During clearing of pump history, the clinician noted the amount administered per pump did not match what amount would have been for the empty syringe.Verbatim: it was reported that a clinician noted the pca syringe near empty, with a second clinician present.During clearing of pump history, the clinician noted the amount administered per pump did not match what amount would have been for the empty syringe.The syringe in question was administered at 2034 on (b)(6) 2021 and was 50mg/50ml bd syringe dilaudid infusion.At the time of syringe change at 0645 on (b)(6) 2021, the syringe was empty, which would mean 50mg administered.Despite syringe being empty, the pump history read only 35.71mg was administered.The clinician called pharmacy and verified tubing was not changed and no priming had occurred.The patient was receiving high doses of medication and concentration of dilaudid 1mg/1ml was used.It was further noted that patient and family had silenced or restarted pumps and were educated not to manage device.There were no adverse effects caused to the patient.
 
Manufacturer Narrative
The following fields have been updated with additional information: g.4.Date received by manufacturer: 2021-04-07.
 
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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 Key12185895
MDR Text Key262203537
Report Number2243072-2021-01900
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
Date FDA Received07/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received04/07/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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