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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 PG PRO 18G 10CM BASIC CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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C.R. BARD, INC. (BASD) -3006260740 PG PRO 18G 10CM BASIC CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number N/A
Device Problem Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/13/2021
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation. A lot history review (lhr) of refn3164 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported midlines that have a flared catheter tips making the insertion difficult for the inserter and patient. It was stated there were several occurrences over the last several weeks. A specific number of occurrences was not provided.
 
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Brand NamePG PRO 18G 10CM BASIC
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
C.R. BARD, INC. (BASD) -3006260740
605 north 5600 west
salt lake city 84116
MDR Report Key12281141
MDR Text Key265176132
Report Number3006260740-2021-03171
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K153280
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Type of Report Initial
Report Date 07/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberF118100
Device Lot NumberREFN3164
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/13/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/01/2021
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: 08/05/2021 Patient Sequence Number: 1
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