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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) 10 ML BD PLASTIPAK¿ SYRINGE, LUER-LOK¿ HYPODERMIC SYRINGE

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BECTON DICKINSON MEDICAL (SINGAPORE) 10 ML BD PLASTIPAK¿ SYRINGE, LUER-LOK¿ HYPODERMIC SYRINGE Back to Search Results
Catalog Number 302149
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/07/2017
Event Type  malfunction  
Manufacturer Narrative
Results: no samples were returned for investigation to determine the nonconformance. A review of the device history record revealed no irregularities during the manufacture of the reported lot # 7206260. Conclusion: without a sample, an absolute root cause for this incident cannot be determined.
 
Event Description
It was reported that a 10 ml bd plastipak¿ syringe, luer-lok¿ would not lock tightly causing the needle to slip off. It was also reported that the device would not lock on the y-site or iv bung. There was no report of injury or medical intervention.
 
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Brand Name10 ML BD PLASTIPAK¿ SYRINGE, LUER-LOK¿
Type of DeviceHYPODERMIC SYRINGE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
Manufacturer (Section G)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key7184280
MDR Text Key97666920
Report Number8041187-2017-00285
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Type of Report Initial
Report Date 12/22/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number302149
Device Lot Number7206260
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/18/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/25/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/11/2018 Patient Sequence Number: 1
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