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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD¿ INSULIN SYRINGE WITH NEEDLE
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BECTON DICKINSON UNSPECIFIED BD¿ INSULIN SYRINGE WITH NEEDLE Back to Search Results
Catalog Number UNKNOWN
Device Problems Loose or Intermittent Connection (1371); Component Missing (2306)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/13/2018
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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.(b)(4) a device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that an unspecified bd¿ insulin syringe with needle was missing a stopper, needle tip and cap were stuck, and the needle cap had loose closure.No serious injury or medical intervention was reported.
 
Event Description
It was reported that an unspecified bd¿ insulin syringe with needle was missing a stopper, needle tip and cap were stuck, and the needle cap had loose closure.No serious injury or medical intervention was reported.
 
Manufacturer Narrative
H.6.Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Unable to perform dhr due to unknown lot number.Based on the samples / photo(s) received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Investigation conclusion: root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: b.2.Event attributed to: other d.8.Device single use?: no h.3.Device returned to manufacturer: no.
 
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Brand Name
UNSPECIFIED BD¿ INSULIN SYRINGE WITH NEEDLE
Type of Device
INSULIN SYRINGE WITH NEEDLE
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key7839850
MDR Text Key119343983
Report Number2243072-2018-01171
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup
Report Date 09/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Date Manufacturer Received08/13/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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