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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. ANGIOCATH 24GA X 0.75IN; INTRAVASCULAR CATHETER
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BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. ANGIOCATH 24GA X 0.75IN; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 38833614
Device Problems Difficult or Delayed Activation (2577); Device Contamination with Chemical or Other Material (2944)
Patient Problem Burning Sensation (2146)
Event Date 10/10/2019
Event Type  malfunction  
Manufacturer Narrative
Initial reporter phone#: (b)(6).Date received by manufacturer: bd was initially made aware of this complaint on (b)(6) 2019.At that time, based on the information provided by the initial reporter, it was evaluated as a non-reportable incident.Additional information was later received on 10/16/2019 that changed the reportability determination.Based on the additional information received, this complaint is considered to be an mdr reportable incident.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 foreign matter occurred during use with a angiocath 24ga x 0.75in.The following information was provided by the initial reporter, "complains that she is having difficulty inferring the catheter from the patient's vein and that patients are complaining that she is burning more than usual.He says the mandrel lubricating gel is agglutinated and stuck to the light.He has already called his distributor who said that the response that bd gave regarding this complaint may be in the packaging of the material transportation, but stressed that the material is used as suggested by the manufacturer.The material is used in cancer patients.Additional information: the customer reports that there is some difficult to remove the needle from the catheter and that the foreign matter seems like bubbles stuck on the external surface of the catheter.".
 
Manufacturer Narrative
H.6.Investigation: bd received 10 unused 24 gauge angiocath units from lot 9059667 for evaluation.A review of the device history record was performed for the reported lot and no quality issues were found during production.Our quality engineer visually inspected the returned units and observed no physical/mechanical damage.Next, a penetration and drag test was performed on the units and no issues were found.Finally, the catheter tips were inspected and each was determined to be acceptable.Based off the visual inspection and testing the units were found to be within product specifications and no defects were observed.The engineer was unable to verify the reported issue and since no defects were found a definitive root cause could not be determined.
 
Event Description
It was reported that foreign matter occurred during use with a angiocath 24ga x 0.75in.The following information was provided by the initial reporter, "complains that she is having difficulty inferring the catheter from the patient's vein and that patients are complaining that she is burning more than usual.He says the mandrel lubricating gel is agglutinated and stuck to the light.He has already called his distributor who said that the response that bd gave regarding this complaint may be in the packaging of the material transportation, but stressed that the material is used as suggested by the manufacturer.The material is used in cancer patients.Additional information: the customer reports that there is some difficult to remove the needle from the catheter and that the foreign matter seems like bubbles stuck on the external surface of the catheter.".
 
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Brand Name
ANGIOCATH 24GA X 0.75IN
Type of Device
INTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
ave. pres.juscelino kubitschek
273 francisco bernardino
juiz de fora
MDR Report Key9559132
MDR Text Key190610025
Report Number9610048-2020-00001
Device Sequence Number1
Product Code FOZ
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 01/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date10/31/2023
Device Catalogue Number38833614
Device Lot Number8303923
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/18/2019
Initial Date Manufacturer Received 10/10/2019
Initial Date FDA Received01/07/2020
Supplement Dates Manufacturer Received10/10/2019
Supplement Dates FDA Received01/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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