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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE HYPODERMIC SYRINGE

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BECTON DICKINSON, S.A. BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE HYPODERMIC SYRINGE Back to Search Results
Catalog Number 300865
Device Problem Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/10/2018
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 a bd plastipak¿ 50ml concentric luer lock syringe became detached from the drug line while the iv was in progress. There was no report of exposure, injury or medical intervention.
 
Manufacturer Narrative
Investigation summary: no samples (or pictures) have been received for investigation. Dhr of lot 1711243 is reviewed, not finding any annotation or deviation regarding the alleged defect. Ten retained samples of lot 1711243 are evaluated. Upon visual inspection of these ten retained samples, no damage or molding defect can be observed in the tip or thread of any of them. Tip and thread verification is done with an iso594 compliant gauge pass/non pass (#(b)(4) respectively) to the first lot manufactured in the month per manufacturing line according to procedure (b)(4). Both verifications are done with these gauges and retained samples according to procedure (b)(4). All samples meet iso594 for both verifications. Final products in this manufacturing line, for this reference and lot size are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures ((b)(4)): 1. Visual inspection: molding: 2 injections per shift. Printing: 32 samples per two hours, after any intervention in the equipment and once at the beginning of the shift. Assembly: 32 samples per two hours, after any intervention in the equipment and once at the beginning of the shift. Primary packaging: 1 advance-step (without product) per hour, after any intervention in the equipment, and once at the beginning of the shift. Secondary packaging: 1 shelf-package per pallet. 2. Functional inspection printing: once in the first pallet and once in last pallet of the lot. Assembly: once in the first pallet and once in last pallet of the lot. Primary packaging: once in the first pallet and once in last pallet of the lot. Investigation conclusion: not confirmed. Since no incident has been found during manufacturing process records related to this defect and according to results obtained from verification with retained samples, no manufacturing defect has been found that could cause the alleged defect and the root cause cannot be determined.
 
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Brand NameBD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE
Type of DeviceHYPODERMIC SYRINGE
Manufacturer (Section D)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
MDR Report Key7342132
MDR Text Key102591095
Report Number3003152976-2018-00074
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Type of Report Initial,Followup
Report Date 03/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number300865
Device Lot Number1711243
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/19/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 03/15/2018 Patient Sequence Number: 1
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