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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 4.5F MICROEZ UNIVERSAL PTFE MICROINTRODUCER SAFETY KIT; INTRODUCER, CATHETER
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C.R. BARD, INC. (BASD) -3006260740 4.5F MICROEZ UNIVERSAL PTFE MICROINTRODUCER SAFETY KIT; INTRODUCER, CATHETER Back to Search Results
Model Number N/A
Medical Device Problem Code Material Frayed (1262)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 09/07/2021
Type of Reportable Event Malfunction
Additional 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 or Problem Description
It was reported "the wire from the introducer kit they opened unraveled after pulling it out of the patient during an unsuccessful picc insertion." no other information was provided.
 
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Brand Name
4.5F MICROEZ UNIVERSAL PTFE MICROINTRODUCER SAFETY KIT
Common Device Name
INTRODUCER, CATHETER
Manufacturer (Section D)
C.R. BARD, INC. (BASD) -3006260740
605 north 5600 west
salt lake city 84116
MDR Report Key12550390
Report Number3006260740-2021-04044
Device Sequence Number3913512
Product Code DYB
UDI-Device Identifier00801741038372
UDI-Public(01)00801741038372
Combination Product (Y/N)N
Initial Reporter StateWV
Initial Reporter CountryUS
PMA/510(K) Number
K915167
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,other
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 09/10/2021
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
Operator of Device Health Professional
Device Model NumberN/A
Device Catalogue Number0678945
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 09/07/2021
Initial Report FDA Received Date09/29/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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