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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT SLIM IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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C.R. BARD, INC. (BASD) -3006260740 POWERPORT SLIM IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR Back to Search Results
Model Number 1716070
Device Problems Device Tipped Over (2589); Blocked Connection (2888)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/23/2019
Event Type  malfunction  
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 not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 06/2022).
 
Event Description
It was reported through the litigation process that approximately two weeks post port device implant, the catheter allegedly had poor and difficult intravascular access and the port flipped sideways in the left chest pocket.It was further reported that a surgery was required to remove the port.The patient was treated using a new port implanted in the right chest.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: the sample was not returned for evaluation, one medical record was provided for review.The investigation is confirmed for the reported port flipped and blocked connection issue.According to the medical record, approximately two weeks post port placement, the left chest port was attempted to be accessed; however, this was unsuccessful.Subsequently, a spot radiograph of the chest revealed left that the catheter appeared to be intact and the left chest port was flipped sideways in the left chest pocket.Four days later, the patient¿s pre-operative diagnosis demonstrated poor and difficult intravascular access.Eventually the left chest port was removed and replaced with new single lumen port.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 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 through the litigation process that approximately two weeks post port device implant, the catheter allegedly had poor and difficult intravascular access and the port flipped sideways in the left chest pocket.It was further reported that a surgery was required to remove the port.The patient was treated using a new port implanted in the right chest.The current status of the patient is unknown.
 
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Brand Name
POWERPORT SLIM IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 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
MDR Report Key12106309
MDR Text Key259590843
Report Number3006260740-2021-02572
Device Sequence Number1
Product Code LJT
UDI-Device Identifier00801741026768
UDI-Public(01)00801741026768
Combination Product (y/n)N
PMA/PMN Number
K072549
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Type of Report Initial,Followup
Report Date 08/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1716070
Device Catalogue Number1716070
Device Lot NumberREDR0742
Was Device Available for Evaluation? No
Date Manufacturer Received08/16/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age54 YR
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