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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 M.R.I. ULTRA SLIMPORT IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

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C.R. BARD, INC. (BASD) -3006260740 M.R.I. ULTRA SLIMPORT IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR Back to Search Results
Catalog Number 0605640
Device Problems Fluid/Blood Leak (1250); Fracture (1260)
Patient Problems Extravasation (1842); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/30/2023
Event Type  Injury  
Manufacturer Narrative
H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The return of the sample is pending.The investigation of the reported event is currently underway.H11: section a through f ¿ the information provided by bd represents all 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.
 
Event Description
It was reported that sometimes post a port placement for chemotherapy treatment, the device allegedly had a subcutaneous leakage.Reportedly, the port system was removed.There was no reported patient injury.
 
Event Description
It was reported that the sometimes post a port placement procedure, the device allegedly had a subcutaneous leakage.It was further reported that a crack was noted near the catheter marker.Furthermore, the patient allegedly experienced extravasation as the drug solution allegedly leaked from the subcutaneous tunnel from the catheter damage site.Reportedly, the port system was removed.The current status of the patient was unknown.
 
Manufacturer Narrative
H10: additional information was received, and the file was reassessed for reportability and determined to be reportable as serious injury.H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.H11: section a through f ¿ the information provided by bd represents all 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.
 
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Brand Name
M.R.I. ULTRA SLIMPORT IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 6F
Type of Device
PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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
brett curtice
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key18422811
MDR Text Key331670302
Report Number3006260740-2023-05958
Device Sequence Number1
Product Code LJT
UDI-Device Identifier00801741025990
UDI-Public(01)00801741025990
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K924250
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/22/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0605640
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/13/2023
Initial Date FDA Received12/30/2023
Supplement Dates Manufacturer Received02/22/2024
Supplement Dates FDA Received03/23/2024
Was Device Evaluated by Manufacturer? No
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) Required Intervention;
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