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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE HYPODERMIC SYRINGE

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BECTON DICKINSON MEDICAL (SINGAPORE) BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE HYPODERMIC SYRINGE Back to Search Results
Catalog Number 300865
Device Problem Burst Container or Vessel (1074)
Patient Problem Exposure to Body Fluids (1745)
Event Date 09/14/2017
Event Type  malfunction  
Manufacturer Narrative
Initial mdr stated 09/14/2014 as the "date received by manufacturer". However, actual date is 09/14/2017. Investigation: no sample neither picture has been received for investigation. Ten retained samples of 50ll lot 1704235p are evaluated. On visual inspection of these ten retained samples, no damage or molding defect can be observed in any of them that could have caused this defect. Dhr of lot 1704235p is reviewed not finding any annotation or deviation regarding the alleged defect. The areas where pieces run in manufacturing area are protected to avoid damage on the product. The ten retained samples are filled with water (with blue colorant for easy visibility) using a 14ga needle, not observing any breakage in the syringe. On inspection at 10x no damage or molding defect can be observed in the tip of these syringes. Tip and thread verification is done with an iso594 reference gauge (#10-419/1 and #10-413) and the ten syringes meet iso594. During manufacturing process, final products are sampled and subjected to visual inspections according to procedures (jg-301, jg-302, jg-303 and jg-304). Process: visual inspection. Printing 30 samples per hour, after any intervention in the equipment or once at the beginning of the shift. Assembly: 30 samples per hour, after any intervention in the equipment or once at the beginning of the shift. Packing 1 step per hour, after any intervention in the equipment, after a stop of more than 1 hour, once at the beginning of the shift, when film or paper roller are changed, after maintenance. Packaging: 1 shelf-package per pallet. Since no incidence has been found during manufacturing process related to this defect, no defect has been found in the ten retained samples evaluated, and the alleged defect cannot be reproduced, the root cause cannot be determined.
 
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. (b)(6). Pma / 510(k) #: there is no 510(k) for this device as it is manufactured outside the us and not sold in the us. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. (b)(4).
 
Event Description
It was reported that a bd plastipak¿ 50ml concentric luer lock syringe exploded during filling. Both the nurse and patient were exposed to blood, but there was no report of injury or medical interventions.
 
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Brand NameBD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE
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 Key6930896
MDR Text Key259430376
Report Number3003152976-2017-00058
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeFR
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 Pharmacist
Type of Report Initial,Followup
Report Date 11/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/09/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number300865
Device Lot Number1704235P
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/09/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/14/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/08/2017
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: 10/09/2017 Patient Sequence Number: 1
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