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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD¿ SYRINGE WITH PERMANENTLY ATTACHED SAFETYGLIDE¿ NEEDLE SYRINGE WITH NEEDLE

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BD MEDICAL - DIABETES CARE BD¿ SYRINGE WITH PERMANENTLY ATTACHED SAFETYGLIDE¿ NEEDLE SYRINGE WITH NEEDLE Back to Search Results
Catalog Number 305945
Device Problems Mechanical Problem (1384); Sticking (1597)
Patient Problems Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)
Event Date 03/27/2018
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Medical device lot #: unknown. Medical device expiration date: unknown. Device manufacture date: unknown. Investigation: a sample is not available for evaluation. A review of the device history record could not be performed as a lot number was not provided for this incident. Without a sample, an absolute root cause for this incident cannot be determined. (b)(6).
 
Event Description
It was reported with the use of the bd¿ syringe with permanently attached safetyglide¿ needle there was an issue with needle sticks to nurses. It was stated ¿ten dirty needle stick injuries have occurred. Unknown batch/lots. Because of the functional use of the slider (white cap); that's what's causing the needle sticks. It's very sticky, not like other products with safety guards. It's just the product. Not the same nurse in any of these instances. ¿ there was no report of further medical intervention.
 
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Brand NameBD¿ SYRINGE WITH PERMANENTLY ATTACHED SAFETYGLIDE¿ NEEDLE
Type of DeviceSYRINGE WITH NEEDLE
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
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key7475836
MDR Text Key106995796
Report Number1920898-2018-00309
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K992734
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation
Type of Report Initial
Report Date 04/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/01/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number305945
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/27/2018
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 Treatment Data
Date Received: 05/01/2018 Patient Sequence Number: 1
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