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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY SYRINGE WITH RETRACTING BD PRECISION GLIDE NEEDLE; SYRINGE PISTON
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BECTON DICKINSON AND COMPANY SYRINGE WITH RETRACTING BD PRECISION GLIDE NEEDLE; SYRINGE PISTON Back to Search Results
Catalog Number REF 305271
Device Problem Detachment of Device or Device Component (2907)
Patient Problems Burning Sensation (2146); Device Embedded In Tissue or Plaque (3165)
Event Date 02/26/2019
Event Type  Injury  
Event Description
During my testosterone injection the bd retracting needle was shot into my upper left buttocks.The spring appears to have been faulty.I have burning in the area of the needle.I am having to get a dr to remove it surgically.Product was a bd integra syringe with retracting bd precision glide needle 3ml 23g x 1 (0.6mm x 25mm), ref 305271, lot 3206402cav05, 07/2018.Have a needle in my buttocks.Needle shows in left buttocks between the skin and the muscle.Fda safety report id# (b)(4).
 
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Brand Name
SYRINGE WITH RETRACTING BD PRECISION GLIDE NEEDLE
Type of Device
SYRINGE PISTON
Manufacturer (Section D)
BECTON DICKINSON AND COMPANY
MDR Report Key8590839
MDR Text Key144459562
Report NumberMW5086436
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 Patient
Type of Report Initial
Report Date 05/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberREF 305271
Device Lot Number3206402CAV05
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/07/2019
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Treatment
MORPHINE SULFATE ER; OTC MEDS: OMEPRAZOLE; OXYCODONE/ACETAMINOPHEN; RX MEDS: KLONOPIN; SILDENAFIL; TESTOSTERONE; VITAMINS
Patient Outcome(s) Other;
Patient Age68 YR
Patient Weight73
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