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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PORT ACCESS NEEDLE; SET, ADMINISTRATION, INTRAVASCULAR
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BARD PORT ACCESS NEEDLE; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number N/A
Device Problems Defective Component (2292); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/06/2021
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
 
Event Description
It was reported that the nurse prepared to carry out maintenance at the infusion port.During the inspection, the needle tip gauze was found with a tiny barb at the tip.The operation was stopped immediately and the operation was resumed with a new needle.
 
Manufacturer Narrative
H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
 
Event Description
It was reported that the nurse prepared to carry out maintenance at the infusion port.During the inspection, the needle tip gauze was found with a tiny barb at the tip.The operation was stopped immediately and the operation was resumed with a new needle.
 
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Brand Name
BARD PORT ACCESS NEEDLE
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
MDR Report Key12278552
MDR Text Key265171410
Report Number3006260740-2021-03154
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
UNK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 09/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/12/2021
Initial Date FDA Received08/04/2021
Supplement Dates Manufacturer Received09/24/2021
Supplement Dates FDA Received10/05/2021
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
Patient Outcome(s) Other;
Patient Age84 YR
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