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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 TI POWERPORT LOW PROFILE; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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C.R. BARD, INC. (BASD) -3006260740 TI POWERPORT LOW PROFILE; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR Back to Search Results
Catalog Number UNK TI POWERPORT LOW PROFILE
Device Problems Disconnection (1171); Migration (4003)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 08/18/2020
Event Type  Injury  
Manufacturer Narrative
As the lot number for the device was not provided, a review of the device history records could not 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.Device not returned.
 
Event Description
It was reported that sometime post port placement, the catheter portion had allegedly separated from the hub and migrated to the right ventricle of the heart.A portion of the catheter was allegedly remained in the left chest.The current status of the patient was unknown.
 
Event Description
It was reported that sometime post port placement, the catheter portion had allegedly separated from the hub and migrated to the right ventricle of the heart.A portion of the catheter was allegedly remained in the left chest.Reportedly, the device was removed and replaced.The current status of the patient was unknown.
 
Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.A definitive root cause could not be determined based upon the available information.Labeling review: a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.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.
 
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Brand Name
TI POWERPORT LOW PROFILE
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 Key15391227
MDR Text Key299567107
Report Number3006260740-2022-03541
Device Sequence Number1
Product Code LJT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K072549
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 11/17/2022
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 NumberUNK TI POWERPORT LOW PROFILE
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/22/2022
Initial Date FDA Received09/09/2022
Supplement Dates Manufacturer Received11/17/2022
Supplement Dates FDA Received11/28/2022
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
Patient Outcome(s) Required Intervention;
Patient SexFemale
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