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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD INTRAVASCULAR ADMINISTRATION SET
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BECTON DICKINSON UNSPECIFIED BD INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number UNKNOWN
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/23/2021
Event Type  malfunction  
Manufacturer Narrative
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.Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and 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 (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.
 
Event Description
It was reported when using the unspecified bd intravascular iv set, the device experienced component separation.The following information was provided by the initial reporter.The customer stated: it was reported by the customer that the tubing came apart by the filter.Verbatim: tubing came apart by filter.
 
Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes d.9.Returned to manufacturer on: 10/15/2021 h.6.Investigation: a complaint of separation at the drip chamber was received from the customer.One used primary set was received by the customer for investigation.Upon visual inspection, it could be observed that the set's drip chamber was disconnected from the tubing.No other defects were observed.The customer's complaint that the tubing came apart was verified.An extension set was received and inspected as well, and no defects were observed.Using the smartsite id on the returned set, the possible material numbers are 2420-0007 and 2420-0004.A device history record review could not be performed because a lot number was not provided by the customer.An investigation was performed by the manufacturing plant.Potential lot numbers of this set were determined during the investigation at the manufacturing plant.The root cause was determined to be partial solvent application on the tubing during manufacturing.The potential lots of this set show that it was manufactured prior to corrective actions being implemented at the plant for this defect.H3 other text : see h.10.
 
Event Description
It was reported when using the unspecified bd intravascular iv set, the device experienced component separation.The following information was provided by the initial reporter.The customer stated: it was reported by the customer that the tubing came apart by the filter.Verbatim: tubing came apart by filter.
 
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Brand Name
UNSPECIFIED BD INTRAVASCULAR ADMINISTRATION SET
Type of Device
INTRAVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer (Section G)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12674891
MDR Text Key278201074
Report Number2243072-2021-02567
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/15/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/09/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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