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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD PRE-FILLED SALINE SYRINGE
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BECTON DICKINSON UNSPECIFIED BD PRE-FILLED SALINE SYRINGE Back to Search Results
Catalog Number UNKNOWN
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Patient Involvement (2645)
Event Date 12/02/2019
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.There are multiple bd locations where this unspecified bd device may have been manufactured.A catalog or a 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.Device expiration date: unknown.Device manufacture date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that a package defect occurred before use with a unspecified bd pre-filled saline syringe.The following information was provided by the initial reporter, i am reaching out to you regarding the ns prefilled saline syringes.I received an email today from the medication management subcommittee.This subcommittee is stating that most of the time nurses are having to bypass scan the prefilled saline syringe because the barcode will not pick up the barcode on the syringes.This has been observed happening in practice and is a common theme across the enterprise.They are wanting to explore if there are other prefilled normal saline syringes that can be purchased that scan more easily.Is this something bd can look into to see if we can come up with a solution?".
 
Manufacturer Narrative
H.6.Investigation summary since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.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.Based on no sample, the investigation concluded, bd was not able to verify the indicated failure.A device history review could not be completed as no batch number was provided.H3 other text : see section h.10.
 
Event Description
It was reported that a package defect occurred before use with a unspecified bd pre-filled saline syringe.The following information was provided by the initial reporter, i am reaching out to you regarding the ns prefilled saline syringes.I received an email today from the medication management subcommittee.This subcommittee is stating that most of the time nurses are having to bypass scan the prefilled saline syringe because the barcode will not pick up the barcode on the syringes.This has been observed happening in practice and is a common theme across the enterprise.They are wanting to explore if there are other prefilled normal saline syringes that can be purchased that scan more easily.Is this something bd can look into to see if we can come up with a solution? ".
 
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Brand Name
UNSPECIFIED BD PRE-FILLED SALINE SYRINGE
Type of Device
PRE-FILLED SALINE SYRINGE
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key9498489
MDR Text Key177362211
Report Number2243072-2019-02867
Device Sequence Number1
Product Code NGT
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 01/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Initial Date Manufacturer Received 12/02/2019
Initial Date FDA Received12/19/2019
Supplement Dates Manufacturer Received12/02/2019
Supplement Dates FDA Received01/13/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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