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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS 3 ML BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE 25 G X 5/8 IN; SYRINGE WITH NEEDLE

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BECTON DICKINSON MEDICAL SYSTEMS 3 ML BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE 25 G X 5/8 IN; SYRINGE WITH NEEDLE Back to Search Results
Catalog Number 309570
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem Foreign Body In Patient (2687)
Event Date 09/28/2017
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 a 3 ml bd luer-lok¿ syringe with attached needle 25 g x 5/8 in broke off into the consumers stomach during use.She was able to remove the needle with tweezers and there was no report of serious injury or medical interventions.
 
Manufacturer Narrative
Bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.Additionally, bd was unable to determine the specific lot number associated with this complaint.Therefore, a review of the device history record could not be conducted.Conclusion: without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode.
 
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Brand Name
3 ML BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE 25 G X 5/8 IN
Type of Device
SYRINGE WITH NEEDLE
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
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key6979452
MDR Text Key90980852
Report Number1213809-2017-00201
Device Sequence Number1
Product Code FMF
UDI-Device Identifier30382903095705
UDI-Public30382903095705
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K980987
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,distributor,other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/05/2018
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 Catalogue Number309570
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/28/2017
Initial Date FDA Received10/26/2017
Supplement Dates Manufacturer Received09/28/2017
Supplement Dates FDA Received01/11/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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) Other;
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