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

Catalog Number	5668362
Medical Device Problem Codes	Component Missing (2306); Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: 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.However, photo was provided for review.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 or Problem Description
A patient underwent a port placement procedure using powerport clearvue isp.It was reported that prior to a port placement procedure, the device was allegedly found with missing some items.Reportedly, the device was allegedly found with wrong items in kit.There was no patient contact.
Event or Problem Description
A patient underwent a port placement procedure using powerport clearvue isp.It was reported that prior to a port placement procedure, the device was allegedly found with missing some items.Reportedly, the device was allegedly found with wrong items in kit.There was no patient contact.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: although the physical device was not returned for evaluation, one electronic photo was provided for review.The photo shows an unsealed product tray containing components such as one port, two right angled non-coring needle, one cathlock, peel-apart sheath and one flushing connector.The investigation is inconclusive for the reported component misassembled and component missing issue as the product was received in an unsealed condition and therefore the original state of the device cannot be confirmed.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.D4 (unique identifier (udi) #), g3, h6 (method, result, conclusion).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.

• Brand Name: POWERPORT CLEARVUE ISP IMPLANTABLE PORT, CHRONOFLEX, 8F
• 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: 23519823
• Report Number: 3006260740-2025-08518
• Device Sequence Number: 9955286
• Product Code: LJT
• UDI-Device Identifier: 00801741110757
• UDI-Public: (01)00801741110757(11)250726(17)270228(10)REKR2724
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K063377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 5668362
• Device Lot Number: REKR2724
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2025
• Supplement Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/26/2025
• 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
• Patient Sex: Unknown