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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 UNIVERSAL MICROINTRODUCER KIT PTFE INTRODUCER, CATHETER

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C.R. BARD, INC. (BASD) -3006260740 UNIVERSAL MICROINTRODUCER KIT PTFE INTRODUCER, CATHETER Back to Search Results
Model Number N/A
Device Problem Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/05/2022
Event Type  malfunction  
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Brand NameUNIVERSAL MICROINTRODUCER KIT PTFE
Type of DeviceINTRODUCER, CATHETER
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
becky garcia
605 north 5600 west
salt lake city 84116
8015950700
MDR Report Key15248513
Report Number3006260740-2022-03201
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K915167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/18/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number0668945
Device Lot NumberREFR1858
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/25/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2021
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: 08/18/2022 Patient Sequence Number: 1
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