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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON IV SET VENTED ARD AP; INTRAVASCULAR ADMINISTRATION SET
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BECTON DICKINSON IV SET VENTED ARD AP; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 388000
Device Problems Leak/Splash (1354); Infusion or Flow Problem (2964)
Patient Problems Underdose (2542); Insufficient Information (4580)
Event Date 01/18/2021
Event Type  malfunction  
Manufacturer Narrative
Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in franklin lakes, nj has been listed and the franklin lakes fda registration number has been used for the manufacture report number.The reported lot # [1018034] was not found for the reported catalog # [388000].Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
 
Event Description
It was reported that infusion fluid/medicine leaked from the iv set vented ard ap and onto the patient.As a result, the patient did not receive the prescribed dose.The following information was provided by the initial reporter: "the infusion tube leaks from the point where you connect it to the iv cannula.Infusion fluid or medicine leaks on patients skin and clothes.Patient did not receive the prescribed dose of medication intended as end result.This product is a new iv set in this department.There has been several leakage incidents since starting to use this product.Most of the problems occur when bcv is attached to the iv-cannula and iv set is connected to bcv.".
 
Event Description
It was reported that infusion fluid/medicine leaked from the iv set vented ard ap and onto the patient.As a result, the patient did not receive the prescribed dose.The following information was provided by the initial reporter: "the infusion tube leaks from the point where you connect it to the iv cannula.Infusion fluid or medicine leaks on patients skin and clothes.Patient did not receive the prescribed dose of medication intended as end result.This product is a new iv set in this department.There has been several leakage incidents since starting to use this product.Most of the problems occur when bcv is attached to the iv-cannula and iv set is connected to bcv.".
 
Manufacturer Narrative
The following fields were updated due to additional information: d.4.Medical device lot #: 1018034.D.4.Medical device expiration date: 2023-06-30.D10: device available for eval yes, d10: returned to manufacturer on: 2021-03-02.H.4.Device manufacture date: 2021-02-22.H6: investigation summary: one 388000 sample was received for investigation of complaint reference (b)(4).No packaging was received with the sample however the customer has indicated that the lot number is 1018034.The sample was received with residual fluid present in the line.No sample of the back check valve, which was reported to be connected to the 388000 at the time of the reported leakage, was received to assist the investigation.In order to try to replicate the customer's experience, the 388000 product was connected to a three-way tap from bd stock and subjected to both fluid and air filled pressure testing; no leakage was observed from the connection of the two products, nor from the male luer component of the 388000 product throughout testing.The details of this feedback were forwarded to the manufacturing site for investigation.It was not possible to confirm the root cause of the customer¿s experience in this instance as testing of the returned sample did not identify any product defects or quality deviations that could have contributed to the customer¿s experience.A review of the production records for lot 1018034 did not identify any in-process testing failures or quality deviations which may have caused or contributed to a report of this nature.A review of the customer feedback database indicates that this is an isolated feedback with no further reports of this nature against the 388000 product in the past 12 months.
 
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Brand Name
IV SET VENTED ARD AP
Type of Device
INTRAVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key11341445
MDR Text Key232350829
Report Number2243072-2021-00350
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
NA
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 03/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date06/03/2023
Device Catalogue Number388000
Device Lot Number1018034
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/02/2021
Date Manufacturer Received03/15/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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