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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 WINGED INFUSION SET WITH INJECTION SITE 20G X 0.75IN SET, ADMINISTRATION, INTRAVASCULAR

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C.R. BARD, INC. (BASD) -3006260740 WINGED INFUSION SET WITH INJECTION SITE 20G X 0.75IN SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number N/A
Device Problem Failure to Infuse (2340)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/26/2022
Event Type  malfunction  
Manufacturer Narrative
The date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event. The device has not been returned to the manufacturer for evaluation, as the device was discarded after the event occurred. A lot history review (lhr) of refp0459 showed three other similar product complaint(s) from this lot number. The complaints for this lot number (refp0459) have been reported from the same facility in (b)(6).
 
Event Description
It was reported that when administering blood or blood products, residues accumulate in the injection port segment, conditioning the risk of bloodstream infection and risk of obstruction. No other information was provided. It was reported this occurred with 4 devices. This report addresses the second device.
 
Manufacturer Narrative
The date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event. The device has not been returned to the manufacturer for evaluation, as the device was discarded after the event occurred. A lot history review (lhr) of refp0459 showed three other similar product complaint(s) from this lot number. The complaints for this lot number (refp0459) have been reported from the same facility in (b)(6).
 
Event Description
It was reported that when administering blood or blood products, residues accumulate in the injection port segment, conditioning the risk of bloodstream infection and risk of obstruction. No other information was provided. It was reported this occurred with 4 devices. This report addresses the second device.
 
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Brand NameWINGED INFUSION SET WITH INJECTION SITE 20G X 0.75IN
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
C.R. BARD, INC. (BASD) -3006260740
605 north 5600 west
salt lake city 84116
Manufacturer (Section G)
BARD REYNOSA S.A. DE C.V. -9617592
blvd. montebello #1
parque industrial colonial
reynosa, tamaulipas 88780
MX 88780
Manufacturer Contact
johanna de oliveira
605 north 5600 west
salt lake city 84116
8015950700
MDR Report Key13552252
MDR Text Key286050764
Report Number3006260740-2022-00406
Device Sequence Number1
Product Code FPA
UDI-Device Identifier00801741065866
UDI-Public(01)00801741065866
Combination Product (y/n)N
Reporter Country CodeMX
PMA/PMN Number
K863606
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 02/17/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/17/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number2205220
Device Lot NumberREFP0459
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/26/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/17/2022 Patient Sequence Number: 1
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