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

Catalog Number	1618001
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A patient was prepped for a port placement procedure using the powerport clearvue slim port.Prior to the procedure, it was reported that the base is cracked.There was no patient contact.
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 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 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.
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: one powerport clearvue slim implantable port with kit components was returned for evaluation.Gross visual, microscopic evaluations were performed.The complaint sample was noted to be clean.Gross examination of the port body showed no puncture access of the port septum.No fracture was observed on port body and port stem.The investigation is unconfirmed for the reported base cracked issue as no fracture was observed on port body and port stem.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.G3, h6 (method, result, conclusion) 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
A patient was prepped for a port placement procedure using the powerport clearvue slim port.Prior to the procedure, it was reported that the base is cracked.There was no patient contact.

• Brand Name: POWERPORT CLEARVUE SLIM IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 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: 24440147
• Report Number: 3006260740-2026-01164
• Device Sequence Number: 21443328
• Product Code: LJT
• UDI-Device Identifier: 00801741026492
• UDI-Public: (01)00801741026492(17)261130(10)REKS0962
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K122899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2026

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: 1618001
• Device Lot Number: REKS0962
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2026
• Supplement Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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