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

Catalog Number	1668362
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Unspecified Infection (1930)
Date of Event	04/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: 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 physical device was not returned for evaluation.No medical records were provided for review.Therefore, the investigation is inconclusive for the reported infection as no objective evidence was provided for review.Furthermore, the clinical conditions alleged in the complaint cannot be confirmed.Based upon 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.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 or Problem Description
It was reported through litigation process that sometime later port placement procedure, the patient developed with unspecified infection.The current status of the patient was unknown.
Additional Manufacturer Narrative
H11: 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 physical device was not returned for evaluation.Medical records were provided for review.The medical records allege that powerport clearvue isp implantable port (catalog no.1668362, lot no.Recr0987) was implanted through the left internal jugular vein for long term total parenteral nutrition.Using imaging guidance, the catheter was advanced through a collateral venous pathway with its tip positioned at the superior cavoatrial junction.Sometime after implantation, the port was removed due to concern for possible infection.Following removal, the catheter tip was sent for culture, which showed heavy serratia marcescens bacterial growth.Therefore, it can be confirmed that the patient had experienced bacterial infection.However, the relationship to the port is unknown.Based upon 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.B3, b5, g3, h6 (patient, method, result).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 or Problem Description
It was reported through the litigation process that, on (b)(6) 2018, a port was implanted via the left internal jugular vein in a patient for long term parenteral nutrition.Approximately nine months and seven days later, on (b)(6) 2019, the port was removed and, the catheter tip culture on the same day confirmed serratia marcescens infection.However, the current status of the patient remains unknown.

• Brand Name: POWERPORT CLEARVUE ISP IMPLANTABLE PORT 8F CHRONOFLEX
• Common Device Name: 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: 22563435
• Report Number: 3006260740-2025-05054
• Device Sequence Number: 9229098
• Product Code: LJT
• UDI-Device Identifier: 00801741110740
• UDI-Public: (01)00801741110740(17)191031(10)RECR0987
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K063377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2026

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: 1668362
• Device Lot Number: RECR0987
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2025
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 38 YR
• Patient Sex: Female
• Patient Weight: 94 KG