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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT VUE, ISP, MR, 8FR, MICRO; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

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C.R. BARD, INC. (BASD) -3006260740 POWERPORT VUE, ISP, MR, 8FR, MICRO; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR Back to Search Results
Catalog Number 1608052
Device Problems Fluid/Blood Leak (1250); Suction Problem (2170)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/11/2023
Event Type  malfunction  
Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.H10: d4 (expiration date: 06/2025).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.H3 other text : device not returned.
 
Event Description
It was reported that sometime post a port placement, the port had allegedly leaked around the access site.It was further reported that the port was allegedly unable to be aspirated.There was no reported patient injury.
 
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Brand Name
POWERPORT VUE, ISP, MR, 8FR, MICRO
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 Key18417962
MDR Text Key331583845
Report Number3006260740-2023-05929
Device Sequence Number1
Product Code LJT
UDI-Device Identifier00801741026423
UDI-Public(01)00801741026423
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K063377
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,User Facility,Company Representative
Reporter Occupation Nurse
Type of Report Initial
Report Date 12/14/2023
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
Device Operator Health Professional
Device Catalogue Number1608052
Device Lot NumberREHU0795
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/11/2023
Initial Date FDA Received12/29/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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