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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO BD PLASTIPAK¿ SYRINGE

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BECTON DICKINSON DE MEXICO BD PLASTIPAK¿ SYRINGE Back to Search Results
Catalog Number 302558
Device Problem Fluid Leak (1250)
Patient Problem Exposure to Body Fluids (1745)
Event Date 04/03/2018
Event Type  Injury  
Manufacturer Narrative
Three potential lot numbers were provided for this incident. The information for each lot number is as follows:  medical device lot #: 7137557, medical device expiration date: 2022-04-30,  device manufacture date: 2017-07-04. Medical device lot #: 7137559, medical device expiration date: 2022-04-30,  device manufacture date: 2017-07-07. Medical device lot #: 8016550, medical device expiration date: 2022-12-31, device manufacture date: 2018-02-27. (b)(6). 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 while using 10ml bd plastipak¿ syringes, there was leakage reported in the body of the syringes. Blood splashed on the face and clothes of the nursing staff and on several patients. There was no report of direct exposure to mucous membranes, serious injury or medical intervention.
 
Manufacturer Narrative
Describe event or problem: the initial mdr did not describe the event correctly. Investigation summary: photos received at bd for investigation for lot number 7137557 and 7137559. Samples were visually evaluated. Dimensional evaluations of the components of the syringe (plunger, barrel and stopper) were also evaluated. A cracked barrel is observed, therefore defect is confirmed. Additionally, a photo was received for lot number 8135550. A slightly inclined cannula is observed, however a cracked barrel is not observed. A device history record review showed no rejected inspections or quality issues during the production of the provided lot numbers that could have contributed to the reported defect. Possible root cause for the defect is occurrence within the process, the dial where the assembly is made may be causing damage to the syringe, however there is a sensor to eject the syringes when they are not well assembled but its functionality has not been 100% effective. Corrective actions include improvements to the assembly line team, as well as staff qualification. In addition, a corrective and preventative action #(b)(4) was generated to follow up on failure modes identified and their respective action plan, given the event of leakage to investigate the defect on this machine. Complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored monthly. Our business team regularly reviews the collected data for identification of emerging trends.
 
Event Description
It was reported that while using 10ml bd plastipak¿ syringes, there was leakage reported in the body of the syringes. Blood splashed on the face and clothes of the nursing staff and on several patients. There was no report of medical intervention.
 
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Brand NameBD PLASTIPAK¿ SYRINGE
Type of DeviceSYRINGE
Manufacturer (Section D)
BECTON DICKINSON DE MEXICO
autopista
55 59 99 8400, k.m. 37.5
cuautitlan izcalli
Manufacturer (Section G)
BECTON DICKINSON DE MEXICO
autopista
55 59 99 8400, k.m. 37.5
cuautitlan izcalli
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key7508674
MDR Text Key108093513
Report Number9614033-2018-00023
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeMX
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number302558
Device Lot NumberSEE H.10.
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/18/2018
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 Treatment Data
Date Received: 05/11/2018 Patient Sequence Number: 1
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