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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE; PISTON SYRINGE
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BECTON DICKINSON MEDICAL SYSTEMS BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE; PISTON SYRINGE Back to Search Results
Catalog Number 305272
Device Problems Leak/Splash (1354); Retraction Problem (1536); Material Separation (1562)
Patient Problem No Information (3190)
Event Date 12/25/2018
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
 
Event Description
It was reported with the use of the bd integra¿ syringe with detachable needle there was an issue with leakage from the syringe as the plunger was depressed.When the plunger was depressed fully the needle did not retract and instead separated from the syringe remaining in the patient.Needle was manually removed.
 
Event Description
It was reported with the use of the bd integra¿ syringe with detachable needle there was an issue with leakage from the syringe as the plunger was depressed.When the plunger was depressed fully the needle did not retract and instead separated from the syringe remaining in the patient.Needle was manually removed.
 
Manufacturer Narrative
Additional information: medical device lot #: 8002923.Medical device expiration date: 12/31/2022.Device manufacture date: 1/2/2018.Investigation summary: two 3ml integra syringes with needles were received and visually inspected.One was loose and one was in an opened blister pack from batch #8002923 (p/n 305272).It was observed that both needles had engaged the retraction mechanism as the metal cutter was exposed through the stopper and the thumb rest was in the correct position just above the top of the barrel.However, both samples had been used and the needle retraction mechanism could not be examined due to unsterile contaminated needles.Therefore, the defect could not be independently confirmed.Furthermore, 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 root cause not defined since defects were not confirmed in samples received.No corrective actions recommended since product defect was not confirmed.
 
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Brand Name
BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
MDR Report Key8277972
MDR Text Key134209028
Report Number1213809-2019-00109
Device Sequence Number1
Product Code MEG
UDI-Device Identifier30382903052722
UDI-Public30382903052722
Combination Product (y/n)N
PMA/PMN Number
K011103
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Type of Report Initial,Followup
Report Date 04/18/2019
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 Other
Device Expiration Date12/31/2022
Device Catalogue Number305272
Device Lot Number8002923
Initial Date Manufacturer Received 01/04/2019
Initial Date FDA Received01/25/2019
Supplement Dates Manufacturer Received01/04/2019
Supplement Dates FDA Received04/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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