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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD¿ INSULIN SYRINGE/NEEDLE INSULIN SYRINGE WITH NEEDLE

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BECTON DICKINSON UNSPECIFIED BD¿ INSULIN SYRINGE/NEEDLE INSULIN SYRINGE WITH NEEDLE Back to Search Results
Catalog Number UNKNOWN
Device Problems Detachment Of Device Component (1104); Structural Problem (2506)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/23/2017
Event Type  malfunction  
Manufacturer Narrative
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 in sections and the (b)(4) fda registration number has been used for the manufacture report number. Date of event: unknown. The date received by manufacturer has been used for this field. The customer's name and address is unknown. (b)(6) has been used as a default. A sample is not available for evaluation. However, a no sample investigation will be completed. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that the packaging on an unspecified bd¿ insulin syringe/needle is weak and the bottom of the bag fell apart when trying to open the top. There was no report of injury or medical interventions.
 
Manufacturer Narrative
Investigation results: severity: s1; occurrence: unable to perform complaint lot history check due to unknown lot number. Unable to perform dhr check due to unknown lot number. 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. Based on the above, no additional investigation and no capa is required at this time.
 
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Brand NameUNSPECIFIED BD¿ INSULIN SYRINGE/NEEDLE
Type of DeviceINSULIN SYRINGE WITH NEEDLE
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key7268497
MDR Text Key100255256
Report Number2243072-2018-00070
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 consumer,other
Type of Report Initial,Followup
Report Date 02/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/23/2017
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 02/13/2018 Patient Sequence Number: 1
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