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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD BD PRECISIONGLIDE NEEDLE 18G X 1 ½ NEEDLE, HYPODERMIC, SINGLE LUMEN

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BD BD PRECISIONGLIDE NEEDLE 18G X 1 ½ NEEDLE, HYPODERMIC, SINGLE LUMEN Back to Search Results
Model Number REF 305196
Device Problem Contamination (1120)
Patient Problem Insufficient Information (4580)
Event Date 02/03/2022
Event Type  malfunction  
Event Description
When removing syringe from wrapper under iso5 conditions, the pharmacy technician noted debris within the needle hub and did not use the product. Fda safety report id # (b)(4).
 
Event Description
When removing syringe from wrapper under iso5 conditions, the pharmacy technician noted debris within the needle hub and did not use the product. Fda safety report id # (b)(4).
 
Event Description
Additional information received from reporter on 3/25/2022 for report mw5107279; a 2022 report from ecri described a potential hazard where bd - 50 ml syringes may contain debris. According to the report, multiple pharmacy technicians have noticed the debris, but lot numbers were not recorded. This information was shared with pharmacy compounding personnel at healthcare. On "x/x/2022," pharmacy personnel at hospital of central (a healthcare facility) noticed debris in a bo - 10 ml syringe upon drawing up a medication. The debris was not seen in the vial prior to withdrawing, was seen in the syringe, and it was seen in the prepared final product which was then discarded. Wrapper and syringe were not saved. This information was shared across healthcare. This was reported to bd and fda medwatch. On "x/x/2022", pharmacy personnel at medical center (a healthcare facility) noticed debris in a bd 18 g 1 ½ in needle hub. The needle was not used for medication preparation. The syringe and over wrapper was saved. Product name: bo precisionglide needle 18g x 1 ½ ref 305196, lot 1120195. This information was shared across healthcare. This was reported to bo and fda medwatch. Communication related to the possibility of debris in sterile product equipment increased awareness and staff diligence prevented use of equipment with debris for the compounding of sterile medication. Circumstances or events have capacity to cause error. (b)(6).
 
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Brand NameBD PRECISIONGLIDE NEEDLE 18G X 1 ½
Type of DeviceNEEDLE, HYPODERMIC, SINGLE LUMEN
Manufacturer (Section D)
BD
MDR Report Key13479921
MDR Text Key285458041
Report NumberMW5107279
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/04/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/07/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberREF 305196
Device Lot NumberLOT 1120195
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No

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