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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE INTEGRA 3ML W/NDL 23X1 RB; PISTON SYRINGE

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BECTON DICKINSON MEDICAL SYSTEMS SYRINGE INTEGRA 3ML W/NDL 23X1 RB; PISTON SYRINGE Back to Search Results
Model Number 305271
Device Problems Break (1069); Leak/Splash (1354); Failure to Deliver (2338)
Patient Problem No Patient Involvement (2645)
Event Date 08/04/2020
Event Type  malfunction  
Manufacturer Narrative
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.(b)(4).
 
Event Description
It was reported that the syringe integra 3 ml w/ndl 23 x 1 rb experienced difficult plunger movement and device damage/deformation.Product defects were noted during use.The following information was provided by the initial reporter: material no.305271, batch no.Unknown (provided: 9093628).No adverse event.Plunger is failing and medication is getting lost.Customer doesn't know how much medication he was administered in his last three uses.
 
Manufacturer Narrative
H.6.Investigation: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.H3 other text : see h.10.
 
Event Description
It was reported that the syringe integra 3ml w/ndl 23x1 rb experienced difficult plunger movement and device damage/deformation.Product defects were noted during use.The following information was provided by the initial reporter: material no.305271, batch no.Unknown (provided: 9093628).No adverse event.Plunger is failing and medication is getting lost.Customer doesn't know how much medication he was administered in his last three uses.
 
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Brand Name
SYRINGE INTEGRA 3ML W/NDL 23X1 RB
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
MDR Report Key10452207
MDR Text Key205315919
Report Number1213809-2020-00570
Device Sequence Number1
Product Code MEG
UDI-Device Identifier30382903052715
UDI-Public30382903052715
Combination Product (y/n)N
PMA/PMN Number
K011103
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup
Report Date 08/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number305271
Device Catalogue Number305271
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/06/2020
Initial Date FDA Received08/25/2020
Supplement Dates Manufacturer Received08/06/2020
Supplement Dates FDA Received08/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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