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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SAFETYGLIDE¿ NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE
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BECTON DICKINSON MEDICAL SYSTEMS BD SAFETYGLIDE¿ NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE Back to Search Results
Catalog Number 305916
Device Problem Complete Blockage (1094)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/07/2022
Event Type  malfunction  
Event Description
It was reported that the bd safetyglide¿ needle was blocked during use.The following information was provided by the initial reporter: "bd¿s post market surveillance process has identified an upward trend in complaints for reported ¿clogged needle¿ condition with 25 g x 1 in.Bd safetyglide¿ needle, material no.305916.Although this is an increase above historical levels, the complaint rates are within accepted limits.Bd investigated the increase and confirmed in some of the returned samples that silicone was present in the tip of the needle.Silicone is part of the needle design and as such has been tested for biocompatibility/toxicity and approved as safe for use in syringe/needle applications.Considering severity and occurrence levels, the overall health risk is deemed low.Bd has made improvements to manufacturing processes and will continue to monitor complaint trends.".
 
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
 
Manufacturer Narrative
H6: investigation summary: as no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.There are current quality controls in place to detect this type of product malfunction during the production process.Based on the limited investigation results, a cause for the reported incident could not be determined.
 
Event Description
It was reported that the bd safetyglide¿ needle was blocked during use.The following information was provided by the initial reporter: "bd¿s post market surveillance process has identified an upward trend in complaints for reported ¿clogged needle¿ condition with 25 g x 1 in.Bd safetyglide¿ needle, material no.305916.Although this is an increase above historical levels, the complaint rates are within accepted limits.Bd investigated the increase and confirmed in some of the returned samples that silicone was present in the tip of the needle.Silicone is part of the needle design and as such has been tested for biocompatibility/toxicity and approved as safe for use in syringe/needle applications.Considering severity and occurrence levels, the overall health risk is deemed low.Bd has made improvements to manufacturing processes and will continue to monitor complaint trends.".
 
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Brand Name
BD SAFETYGLIDE¿ NEEDLE
Type of Device
HYPODERMIC SINGLE LUMEN NEEDLE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
Manufacturer (Section G)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key16038395
MDR Text Key308463837
Report Number1213809-2022-01302
Device Sequence Number1
Product Code FMI
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K951254
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/23/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number305916
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/23/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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