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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 Material Puncture/Hole (1504)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/11/2022
Event Type  malfunction  
Event Description
It was reported that the unspecified bd catheter experienced the needle through catheter.The following information was provided by the initial reporter, translated from portuguese to english: the patient was punctured with an intravenous catheter 20 plus the same when introducing the siliconized needle with a bi-angled bevel, breaking the silicone at the tip, bursting the vein.Punctured again with abocath 20 and the vein ruptures.
 
Manufacturer Narrative
Investigation summary: as no physical sample, valid part number 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.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 franklin lakes, nj has been listed and the franklin lakes fda registration number has been used for the manufacture report number.
 
Manufacturer Narrative
H6: investigation summary as no physical sample, valid part number 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.A device history review could not be completed as no batch number was provided.
 
Event Description
It was reported that the unspecified bd catheter experienced the needle through catheter.The following information was provided by the initial reporter, translated from portuguese to english: the patient was punctured with an intravenous catheter 20 plus the same when introducing the siliconized needle with a bi-angled bevel, breaking the silicone at the tip, bursting the vein.Punctured again with abocath 20 and the vein ruptures.
 
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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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key16369084
MDR Text Key309503832
Report Number2243072-2023-00206
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/17/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/13/2023
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 Received02/17/2023
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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