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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 X-PORT ISP IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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C.R. BARD, INC. (BASD) -3006260740 X-PORT ISP IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR Back to Search Results
Catalog Number 0607540
Device Problems Difficult to Flush (1251); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pulmonary Embolism (1498); Bacterial Infection (1735); Unspecified Infection (1930); Neck Pain (2433); Swelling/ Edema (4577)
Event Date 08/07/2019
Event Type  Injury  
Event Description
It was reported through litigation process that sometime post a port placement, the patient allegedly developed infection.However, the current status of the patient is unknown.
 
Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not requested as the lot number reported as unknown.Investigation summary: the device was not returned for evaluation.Medical records were not provided.Therefore, the investigation is inconclusive for the reported adverse event as no objective evidence was provided for review.Furthermore, the clinical conditions alleged in the complaint cannot be confirmed.Based on the available information, the definitive root cause is unknown.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.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.
 
Manufacturer Narrative
H10: 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.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.H3 other text : device not returned.
 
Event Description
It was reported through litigation process that seven years, six months, and ten days post a port placement via the right subclavian vein, the patient was allegedly diagnosed with filling defect in the lateral basal segment pulmonary artery of the left lower lobe.It was further reported that the port was unable to be flushed.It was also reported that the patient allegedly experienced neck pain, swelling and was diagnosed with bacterial infection as the blood culture resulted growth of staphylococcus lugdunensis from the infected port.Reportedly, the port was removed from the patient.However, the current status of the patient is unknown.
 
Event Description
It was reported through litigation process that seven years, six months, and ten days post a port placement via the right subclavian vein, the patient was allegedly diagnosed with filling defect in the lateral basal segment pulmonary artery of the left lower lobe.It was further reported that the port was unable to be flushed.It was also reported that the patient allegedly experienced neck pain, swelling and was diagnosed with bacterial infection as the blood culture resulted growth of staphylococcus lugdunensis from the infected port.Reportedly, the port was removed from the patient.However, 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 device was not returned for evaluation.Medical records were provided.The medical record alleges the bard implantable port was implanted at the right subclavian vein for the patient with lymphoma and prior to this put placement two-bard port was implanted no malfunction been reported.The implant procedure was carried out by making an insertion and creating a port packet and create a tubing through the subcutaneous tunnel into the sheath where the catheter tip was at the junction of the superior vena cava on the right atrium.Then the tubing was connected and the port was placed in the packet.The fluoroscopy of chest reveal the insertion of the port and catheter and the catheter tip was seen close to the superior vena cava right atrial junction.Approximately 6 years and six months later a computer tomography of chest , abdomen and pelvis revealed filling defects in the lateral basal segment of pulmonary artery to the left lower lobe and concerning for a small segmental pulmonary embolism.On the same day the mediport was positive of blood turn but remained unable to flush after the cathflow administration.After 21 days later you just radiography was taken for the history of chest pain anti mediport catheter with the bus system anomalous cranial course of catheter with tip outside the field of view was observed.After 11 month later the chest radiograph showed the mediport catheter with the persistent anomalous cranial course of catheter and with the tip outside the field of view.Approximately again four months later we just radiograph showed detective coursing cranially along the right internal jugular vein.Approximately 2 weeks later the chest radiograph showed the catheter tip was extending into the right jugular vein.After eight months later the patient complained of port not working and wanted to be removed.After four months later the computer tomography of neck and chest was performed for the chest discomfort, upper neck pain or swelling around the port that the patient stated was clotted and incorrectly positioned and was going to be removed.After five weeks later the patient was seen and determined for the removal of the infected nonfunctional port come on the patient stated of having cold for few weeks ago but no other complication, on the same date the port was removed from the patient upon the post removal of the port the patient had grew the sign of staphylococcus lugdnensis on multiple preoperative blood cultures likely from the infected both side which was removed.As the medical device confirms the port was unable to flush and the investigation was also confirming the same device malfunction.Additionally, it can be confirmed that the patient experienced pe, neck pain, swelling, bacterial infection.However, the relationship to the port is unknown.Furthermore, the clinical condition alleged in the complaint cannot be confirmed.Based on the available information, the definitive root cause is unknown.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiration date: 08/2017).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
X-PORT ISP IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 8F
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 Key18996794
MDR Text Key338883388
Report Number3006260740-2024-01339
Device Sequence Number1
Product Code LJT
UDI-Device Identifier00801741026188
UDI-Public(01)00801741026188
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K022983
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Consumer,Health Professional
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 05/27/2024
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 Number0607540
Device Lot NumberREWL0689
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/28/2024
Supplement Dates Manufacturer Received04/22/2024
05/27/2024
Supplement Dates FDA Received05/17/2024
06/04/2024
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) Life Threatening; Required Intervention;
Patient Age61 YR
Patient SexMale
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