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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD CATHETER; INTRAVASCULAR CATHETER

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BECTON DICKINSON UNSPECIFIED BD CATHETER; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number UNKNOWN
Device Problem Improper Flow or Infusion (2954)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/18/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.Medical device expiration date: unknown.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.Investigation summary: as no physical sample, material and/or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.Based on the limited investigation results, a cause for the reported incident could not be determined.Examination of the product involved may provide clarification as to the cause for the reported failure.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
 
Event Description
It was reported that an unspecified bd catheter split.The following information was provided by the initial reporter: " it was reported by the distributor that the catheter split in two during insertion.".
 
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Brand Name
UNSPECIFIED BD CATHETER
Type of Device
INTRAVASCULAR CATHETER
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 Key12186161
MDR Text Key265204647
Report Number2243072-2021-01909
Device Sequence Number1
Product Code FOZ
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
Report Date 07/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/17/2021
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? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/18/2021
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 Sequence Number1
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