MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT CLEARVUE ISP IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 1608062

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Extravasation (1842); Unspecified Infection (1930)

Event Date 02/07/2022

Event Type  Injury  

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not requested as the lot number reported is 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.

Event Description

It was reported through litigation process that sometime post a port placement, the patient allegedly developed with infection.However, the current status of the patient is unknown.

Event Description

It was reported through the litigation process that ten months and fourteen days post a port placement via the right internal jugular vein, it was alleged that two small sites along the supraclavicular portion of the catheter appeared to have micro perforations and it was evidenced by contrast extravasation at these sites.It was further reported that the patient allegedly developed with infection.Reportedly, the infected port was removed.The current status of the patient is unknown.

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.H10: d4 (expiry date: 03/2022), g2, g3.H6 (patient).H11: b3, b5, d4 (medical device lot number), h6 (device, result, conclusion).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.

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 and reviewed.The medical record alleges that the bard implantable port was placed at the atriocaval junction to the right internal jugular vein.The port was flushed with heparin saline solution and the patient tolerated the procedure well.Approximately ten months and fourteen days later, on the right-side of chest under sterile condition, the scout image demonstrates a normal expected course of the port catheter without evidence of kinking or gross dislodgement.The contrast was slowly injected, two small sites along the supraclavicular of the catheter appeared to have micro perforation as evidenced by the contrast extravasation at this site.The catheter was flushed with saline and locked with a heparin.Approximately fifteen days later, under the fluoroscopic guidance, the right sided chest port was removed.On the same day to the left internal jugular vein, another bard implantable port was placed at the atriocaval junction.The port was then flushed with heparinized saline solution and the patient tolerated the procedural well.There was no immediate complication.After a month later, the patient was admitted to hospital for secondary pain, redness, and discharge around the port side.Oncologist found the drainage of pus.The blood culture of the test confirms that the patient allegedly developed with methicillin resistant staphylococcus aureus bacterial infection as a result of defective infected port.Two days later, the infected port was removed, and the patient was treated with the intravenous cefepime, vancomycin and daptomycin.The submitted medical record confirms the evidence of catheter hole, and leakage, and the investigation confirms the reported device allegations.Additionally, it can be confirmed that the patient experienced 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: (expiration date: 03/2022).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 through the litigation process that ten months and fourteen days post a port placement via the right internal jugular vein, it was alleged that two small sites along the supraclavicular portion of the catheter appeared to have micro perforations and it was evidenced by contrast extravasation at these sites.It was further reported that the patient allegedly developed with an infection.Reportedly, the infected port was removed.The current status of the patient is unknown.

• Brand Name: POWERPORT CLEARVUE 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 Key: 18675176
• MDR Text Key: 335004610
• Report Number: 3006260740-2024-00428
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741026430
• UDI-Public: (01)00801741026430
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063377
• Number of Events Reported: 1
• 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: 05/07/2024

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 Number: 1608062
• Device Lot Number: REEX0612
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/22/2024
• Initial Date FDA Received: 02/09/2024
• Supplement Dates Manufacturer Received: 03/18/2024; 05/07/2024
• Supplement Dates FDA Received: 04/13/2024; 05/08/2024
• 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 Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 120 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White