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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. PICC; CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS
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C.R. BARD, INC. PICC; CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS Back to Search Results
Lot Number REGT3376
Device Problems Difficult to Insert (1316); Material Integrity Problem (2978); Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/14/2022
Event Type  malfunction  
Event Description
While inserting single lumen picc line, met resistance.Patient had right sided port a cath.Several times pulling back picc and advancing to get past resistance.3cg wire inspected and found to be sharply kinked, and integrity too compromised to continue to use.3cg wire removed from procedure and obtained a new wire from new kit to complete procedure.Comment: no harm to patient.Wire saved for return to bd for analysis.Manufacturer response for picc line, single lumen picc line (per site reporter) retrieved sample.Notified rep and requested rma & mailer.Bd assigned complaint# (b)(4).[redacted name] responded to bd's questions and requested rma/mailer materials.
 
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Brand Name
PICC
Type of Device
CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS
Manufacturer (Section D)
C.R. BARD, INC.
8195 industrial blvd
covington GA 30014
MDR Report Key16111944
MDR Text Key306801101
Report Number16111944
Device Sequence Number1
Product Code LJS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Lot NumberREGT3376
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/19/2022
Event Location Hospital
Date Report to Manufacturer01/06/2023
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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