MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT CLEARVUE SLIM IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 1616000

Device Problems Fluid/Blood Leak (1250); Fracture (1260); Blocked Connection (2888); Material Integrity Problem (2978)

Patient Problems Extravasation (1842); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/13/2024

Event Type  Injury  

Manufacturer Narrative

H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.However, photo and image were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 05/2025) 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 pending return.

Event Description

It was reported that one week four days post a port placement, leak allegedly occurred at site of catheter connection to the port hub.It was further reported that port was unable to access and catheter was damaged.Reportedly, the patient had pain, foul smell, pocket swabbed and prophylactic antibiotics were administered.Reportedly, patient was sent to interventional radiology to access with fluoro for the port removal.Port was removed and new line placed.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 clearvue slim implantable port attached to a catheter was returned for evaluation.Functional, gross visual, tactile and microscopic visual evaluations were performed.Multiple splits were noted throughout the proximal end of the catheter distal to the cath-lock.A complete circumferential break was noted on the distal end of the attached catheter.Upon infusion, small leaks from the attached catheter specifically from the proximal portion, was observed while water with thrombus exited the distal end of the attached catheter.Aspiration was attempted and was unsuccessful.Also one photo and one image was provided for review.The image depicts the device inserted via a right jugular access.However, the catheter integrity appears unremarkable.The photo shows the clinician was infusing a solution through the port and the solution was noted to be leaking through the catheter near the cathlock area.Therefore the investigation is confirmed for the reported catheter damage, fluid leak and identified fracture issues.However the investigation is inconclusive for the blocked connection issue as the reported event cannot be confirmed from the provided photos.The definitive root cause could not be determined based upon available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiry date: 05/2025), g3, h6 (patient, device).H11: b5, h6 (method, 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.

Event Description

It was reported that approximately nine days post port placement, during the first treatment care, the port was allegedly unable to be clearly accessed.It was further reported that an alleged subcutaneous leak with contrast extravasation was identified at site of catheter connection to the port hub under fluoroscopy contrast injection.Reportedly, the patient had pain, foul smell, pocket swabbed and started on prophylactic antibiotics.The port was removed in the interventional radiology, and a new line was placed.The patient was reported as stable.

• Brand Name: POWERPORT CLEARVUE 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
• 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: 19085904
• MDR Text Key: 339876539
• Report Number: 3006260740-2024-01623
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741026447
• UDI-Public: (01)00801741026447
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/17/2024

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: 1616000
• Device Lot Number: REHX2978
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2024
• Initial Date FDA Received: 04/11/2024
• Supplement Dates Manufacturer Received: 05/17/2024
• Supplement Dates FDA Received: 05/28/2024
• 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 Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 5 YR
• Patient Sex: Male
• Patient Weight: 29 KG
• Patient Race: White