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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SAFETYGLIDE; SAFETYGLIDE NEEDLES
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BD MEDICAL - DIABETES CARE BD SAFETYGLIDE; SAFETYGLIDE NEEDLES Back to Search Results
Catalog Number 305950
Device Problem Packaging Problem (3007)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/01/2024
Event Type  malfunction  
Event Description
It was reported that the bd safetyglide package was damaged, defective.The following information was provided by the initial reporter: "the item is damaged and no longer sterile.There is a giant hole on the top left of the item." additional information received on 02/27/24: ¿per the customer the one is in the packaging.¿.
 
Manufacturer Narrative
B.3.The date received by manufacturer has been used for this field.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
 
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Brand Name
BD SAFETYGLIDE
Type of Device
SAFETYGLIDE NEEDLES
Manufacturer (Section D)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
Manufacturer (Section G)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
Manufacturer Contact
helen cox (mdr)
75 north fairway drive
vernon hills, IL 60061
8473935694
MDR Report Key18799014
MDR Text Key337420424
Report Number1920898-2024-00074
Device Sequence Number1
Product Code MEG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K992734
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/03/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number305950
Device Lot Number3131651
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/01/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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