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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD INTEGRA 3ML SYRINGE; ANTISTICK SYRINGE

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BECTON DICKINSON MEDICAL SYSTEMS BD INTEGRA 3ML SYRINGE; ANTISTICK SYRINGE Back to Search Results
Model Number 305269
Device Problems Break (1069); Defective Component (2292)
Patient Problems Swelling/ Edema (4577); Insufficient Information (4580)
Event Date 12/27/2021
Event Type  Injury  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that bd integra 3ml syringe experienced difficult plunger movement, clogged needle, and a needle that broke.The product defects led to the patient receiving medical intervention.They were admitted to the emergency room where they received x-ray scans, but a broken portion of the cannula was not found.Muscle damage was discovered, likely from pushing too hard on the syringe.The following information was provided by the initial reporter: stated, she took her son to emergency room.Stated, a few xrays were taken and there was no needle found.Stated, she was told there was some muscle damaged that could have been caused from pushing syringe too hard or infection.Stated, her son was told to take ibuprofen for the swelling and follow up if swelling does not go down.Parent reported, needle broke off into her son's arm when she was administering his shot.Stated, she had to push really hard on the syringe to get medication to come out.Stated, when using the syringes from this lot, she has to push really hard because medication is too thick stated, her son's arm is now "swollen and hard to the touch".
 
Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that bd integra 3ml syringe experienced difficult plunger movement, clogged needle, and a needle that broke.The product defects led to the patient receiving medical intervention.They were admitted to the emergency room where they received x-ray scans, but a broken portion of the cannula was not found.Muscle damage was discovered, likely from pushing too hard on the syringe.The following information was provided by the initial reporter: stated, she took her son to emergency room.Stated, a few xrays were taken and there was no needle found.Stated, she was told there was some muscle damaged that could have been caused from pushing syringe too hard or infection.Stated, her son was told to take ibuprofen for the swelling and follow up if swelling does not go down.Parent reported, needle broke off into her son's arm when she was administering his shot.Stated, she had to push really hard on the syringe to get medication to come out.Stated, when using the syringes from this lot, she has to push really hard because medication is too thick stated, her son's arm is now "swollen and hard to the touch".
 
Event Description
It was reported that bd integra 3ml syringe experienced difficult plunger movement, clogged needle, and a needle that broke.The product defects led to the patient receiving medical intervention.They were admitted to the emergency room where they received x-ray scans, but a broken portion of the cannula was not found.Muscle damage was discovered, likely from pushing too hard on the syringe.The following information was provided by the initial reporter: stated, she took her son to emergency room.Stated, a few xrays were taken and there was no needle found.Stated, she was told there was some muscle damaged that could have been caused from pushing syringe too hard or infection.Stated, her son was told to take ibuprofen for the swelling and follow up if swelling does not go down.Parent reported, needle broke off into her son's arm when she was administering his shot.Stated, she had to push really hard on the syringe to get medication to come out.Stated, when using the syringes from this lot, she has to push really hard because medication is too thick stated, her son's arm is now "swollen and hard to the touch".
 
Manufacturer Narrative
The following fields were updated due to additional information: device available for eval yes.Returned to manufacturer on: 2022-02-22.Investigation summary one loose 3ml integra syringe (p/n 305269) was received and evaluated.There was also a top web slip with the batch # 9268944 on it.The sample was an activated integra syringe with the needle present in the bottom of the outer plunger rod.No visual defects were observed on the syringe.Please note that this product has a retractable needle design.The metal cannula of the needle retracts into the inner plunger rod for safety.Since the sample received did not display the reported condition a potential root cause could not be defined, and corrective actions are not necessary.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.
 
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Brand Name
BD INTEGRA 3ML SYRINGE
Type of Device
ANTISTICK SYRINGE
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 Key13320947
MDR Text Key285716364
Report Number1213809-2022-00011
Device Sequence Number1
Product Code MEG
UDI-Device Identifier30382903052692
UDI-Public30382903052692
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K011103
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Consumer
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/01/2022
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 Lay User/Patient
Device Expiration Date09/30/2024
Device Model Number305269
Device Catalogue Number305269
Device Lot Number9268944
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/31/2021
Initial Date FDA Received01/21/2022
Supplement Dates Manufacturer Received03/01/2022
Supplement Dates FDA Received03/19/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/25/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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