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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT TI L/P 6 CF INT WSP ATT SL; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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C.R. BARD, INC. (BASD) -3006260740 POWERPORT TI L/P 6 CF INT WSP ATT SL; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR Back to Search Results
Catalog Number 8716000
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Thrombosis/Thrombus (4440); Swelling/ Edema (4577); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/21/2022
Event Type  Injury  
Event Description
It was reported that one month fifteen days post port placement procedure, the patient allegedly had soreness and puffiness on the right side of the port.There was no reported patient injury.
 
Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.Udi # (expiration date: 05/2024).
 
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 provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.H10: d4 (expiration date: 05/2024).H11: section a through f ¿ the information provide 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 one month fifteen days post port placement procedure, the patient allegedly had soreness and puffiness on the right side of the port.It was further reported that blood clot in main artery caused soreness and puffiness.Reportedly, blood thinners were given to treat blood clot.The current status of the patient is unknown.
 
Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one powerport implantable port attached to catheter was returned for evaluation.Gross visual, microscopic visual, tactile and functional testing were performed.The investigation is inconclusive for the reported issue as the exact circumstances at the time of reported event is unknown and however clinical conditions cannot be replicated to confirm these failures.Furthermore, the clinical conditions alleged in the complaint cannot be confirmed.A definitive root cause could not be determined, patient anatomy and/or allergies to materials or chemicals used during procedure could have caused the reported event.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 provide 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 one month fifteen days post port placement procedure, the patient allegedly had soreness and puffiness on the right side of the port.It was further reported that blood clot in main artery caused soreness and puffiness.Reportedly, blood thinners were given to treat blood clot.The current status of the patient is unknown.
 
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Brand Name
POWERPORT TI L/P 6 CF INT WSP ATT SL
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 Key15823533
MDR Text Key304123948
Report Number3006260740-2022-05356
Device Sequence Number1
Product Code LJT
UDI-Device Identifier00801741098932
UDI-Public(01)00801741098932
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,Followup
Report Date 12/27/2022
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 Number8716000
Device Lot NumberREGT1325
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/15/2022
Initial Date Manufacturer Received 10/21/2022
Initial Date FDA Received11/18/2022
Supplement Dates Manufacturer Received11/01/2022
01/04/2023
Supplement Dates FDA Received11/30/2022
01/04/2023
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) Required Intervention;
Patient SexFemale
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