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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE LUER-LOK¿ TIP; PISTON SYRINGE

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BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE LUER-LOK¿ TIP; PISTON SYRINGE Back to Search Results
Catalog Number 302995
Device Problem Crack (1135)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/01/2018
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that during use of the bd syringe luer-lok¿ tip the syringe was cracked.
 
Manufacturer Narrative
Investigation summary: one loose 10ml syringe and one opened package, confirmed to be from batch #8158756 (p/n 302995), were received.The sample was visually evaluated.The sample had a label attached and appeared used with liquid residue inside, therefore evaluation was performed through the sample bag.A small scratch approximately 1/2¿ long was observed at the level of 1ml outside the scale markings.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.It is possible the observed scratch was the crack reported by the customer, although it could not be definitively confirmed.Potential root cause for the scratch/crack is associated with the assembly process.No corrective actions are necessary based on the defective rate identified.
 
Event Description
It was reported that during use of the bd syringe luer-lok¿ tip the syringe was cracked.
 
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Brand Name
BD SYRINGE LUER-LOK¿ TIP
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
MDR Report Key8191271
MDR Text Key131340061
Report Number1213809-2018-00932
Device Sequence Number1
Product Code FMF
UDI-Device Identifier30382903029953
UDI-Public30382903029953
Combination Product (y/n)N
PMA/PMN Number
K980987
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 03/18/2019
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 Date05/31/2023
Device Catalogue Number302995
Device Lot Number8158756
Initial Date Manufacturer Received 12/07/2018
Initial Date FDA Received12/21/2018
Supplement Dates Manufacturer Received12/07/2018
Supplement Dates FDA Received03/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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