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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BARD PICC; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
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C.R. BARD, INC. (BASD) -3006260740 BARD PICC; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS Back to Search Results
Model Number N/A
Device Problem Restricted Flow rate (1248)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/05/2021
Event Type  malfunction  
Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
 
Event Description
It was reported that a dl solo picc pressured out at 200 psi, not making it to 300 psi.It was stated they tried this in a patient and outside a patient mock setting."we had the contract cold and warmed it still only met the 200 psi didn't reach 300 psi.The machine is set to 300 psi.".
 
Manufacturer Narrative
H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint that the catheter was not reaching 300 psi was inconclusive as the affected product was not returned for investigation.One unopened picc kit (s1294108d4) from lot #reft2253 was returned for investigation.The components in the kit exhibited no damage or defect.A functional test of the catheter showed no occlusions or restrictions within the catheter.The dimensions of the catheter lumens were within specification.While the affected catheter may have partially occluded during use, the unused returned sample showed no damage.For the 4 fr dual-lumen catheter, the information provided in the picc kit indicates an internal catheter pressure of 237 psi during power injection at 5 ml/sec with injection safety cut-off at 300 psi, using contrast media with 11.8 cp viscosity.Since the affected product was not returned, the exact cause of the reported event could not be determined.H3 other text : evaluation findings are in section h.11.
 
Event Description
It was reported that a dl solo picc pressured out at 200 psi, not making it to 300 psi.It was stated they tried this in a patient and outside a patient mock setting."we had the contract cold and warmed it still only met the 200 psi didn¿t reach 300 psi.The machine is set to 300 psi.".
 
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Brand Name
BARD PICC
Type of Device
CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
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
kelsey erickson
605 north 5600 west
salt lake city 84116
8015950700
MDR Report Key12861991
MDR Text Key281154430
Report Number3006260740-2021-04977
Device Sequence Number1
Product Code LJS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/22/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/26/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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