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

Catalog Number 5618000

Device Problems Fluid/Blood Leak (1250); Fracture (1260); Material Split, Cut or Torn (4008)

Patient Problems Extravasation (1842); Swelling/ Edema (4577)

Event Date 03/22/2024

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history records could not be performed.The return of the sample is pending.The investigation of the reported event is currently underway.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 three years post a port placement via the internal jugular approach, upon removal, the catheter was allegedly found to have a clean cut under the plastic connector where the cuff connects to the port hub and had a torn appearance similar to a hangnail.It was further reported that upon a contrast study, contrast extravasation was allegedly seen at the base of the internal jugular.Furthermore, the patient allegedly experienced swelling at the base of the neck during chemotherapy infusion.Reportedly, the port was removed and replaced.The current status of the patient was 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 clearvue slim implantable port attached to a catheter was returned for evaluation.Visual, microscopic, tactile and functional evaluations were performed on the returned device.A partial compound break was noted to the proximal end of the attached catheter.The edges of the partial compound break on the attached catheter were noted to be uneven and the surface was noted to be granular throughout both regions.Upon infusion, a leak from the partial compound break was observed on the attached catheter.Therefore the investigation is confirmed for the reported fluid leak and the identified fracture issues.However the investigation is unconfirmed for the reported material cut issue as no cut was noted upon evaluation and only a partial break was identified.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: 12/2022), g3, h6 (device).H11: d4, 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 three years post a port placement via the internal jugular approach, upon removal, the catheter was allegedly found to have a clean cut under the plastic connector where the cuff connects to the port hub and had a torn appearance similar to a hangnail.It was further reported that upon a contrast study, contrast extravasation was allegedly seen at the base of the internal jugular.Furthermore, the patient allegedly experienced swelling at the base of the neck during chemotherapy infusion.Reportedly, the port was removed and replaced.The current status of the patient was unknown.

• Brand Name: POWERPORT CLEARVUE SLIM IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 8F
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASULAR
• 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: 19193742
• MDR Text Key: 341170084
• Report Number: 3006260740-2024-01943
• Device Sequence Number: 1
• Product Code: LJT
• 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: 05/27/2024

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 Number: 5618000
• Device Lot Number: REFX1930
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2024
• Initial Date FDA Received: 04/26/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/29/2024
• 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