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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PRESET ARTERIAL BLOOD COLLECTION SYRINGE
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BECTON DICKINSON, S.A. BD PRESET ARTERIAL BLOOD COLLECTION SYRINGE Back to Search Results
Catalog Number 515303
Device Problem Leak/Splash (1354)
Patient Problem Chemical Exposure (2570)
Event Date 04/29/2019
Event Type  malfunction  
Manufacturer Narrative
(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 leakage occurred with a bd preset¿ arterial blood collection syringe.The following information was provided by the initial reporter, "in a cisplatin infusion in a nacl 0.9% carrier solution with a volumen of 500 ml, the solution exited the infusion set due to the open tubing clamp through the access of the infusion device and cw (cytostatics) passed over to the nurse hands.Due to the cmr (cancerogen, mutagen, reproductionstoxic) potential of the substance there is a potential carcinogenic risk for the employee.
 
Event Description
It was reported that leakage occurred with a bd preset¿ arterial blood collection syringe.The following information was provided by the initial reporter, "in a cisplatin infusion in a nacl 0.9% carrier solution with a volumen of 500 ml, the solution exited the infusion set due to the open tubing clamp through the access of the infusion device and cw (cytostatics) passed over to the nurse hands.Due to the cmr (cancerogen, mutagen, reproductionstoxic) potential of the substance there is a potential carcinogenic risk for the employee.
 
Manufacturer Narrative
H.6.Investigation summary: no samples or photos of lot ta11163 were provided for investigation.A device history review was performed and found no non-conformances associated with this issue during the production of this batch.The final product for lot ta11163 is assembled and packaged at a supplier site.We have notified the supplier of the reported issue.Three retained samples from the reported lot were used for additional evaluation.There were no visual defects noted and the dimensional inspection verified the product was manufactured properly.Functional evaluations were conducted and in all cases the clamp performed as expected.Based on available information, since we were unable to duplicate the indicated failure mode and review of the device history records showed no indication of the alleged defect, we were not able to identify a root cause related to the manufacturing process at this time.A project has been initiated to enhance the design of the clamp, improving use and overall customer satisfaction with the device.Complaints for this device and defect will continue to be monitored by our quality team for signs of emerging trends.Conclusion: taking into account the complaints trend history (not related complaints with confirmed manufactured issues) and the kind of the reported issue (not related with the manufacturing process), the most probable root cause seems that the differences between the new c70 (manufactured in almaraz) and the previous c70 have not been clearly explained to the customers.A project has been opened to enhance the design of the claimed product.The primary change involves replacing the material of the current pinch clamp (made of polypropylene) by (polyoxymethylene), a stiffer material, enhancing the use and the customer satisfaction have been approved for the project implementation.H3 other text : see section h.10.
 
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Brand Name
BD PRESET ARTERIAL BLOOD COLLECTION SYRINGE
Type of Device
SYRINGE
Manufacturer (Section D)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
MDR Report Key8659941
MDR Text Key151015060
Report Number3003152976-2019-00370
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,other,user facility
Type of Report Initial,Followup
Report Date 08/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/31/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date10/31/2022
Device Catalogue Number515303
Device Lot NumberTA11163
Date Manufacturer Received05/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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