MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT SLIM TI W 6FR CHRONOFLEX WO SP, INTER. KIT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number	1716001
Medical Device Problem Codes	Suction Problem (2170); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a patient underwent an port placement procedure using the powerport slim ti.It was reported that the port could not draw back while the catheter was in the saline bowl, and air bubbles were observed despite multiple checks.The team verified all connections, changed syringes, and replaced the access needle, but the issue persisted.Consequently, the decision was made not to use the affected port and instead place a different port.There was no reported patient injury.
Additional Manufacturer Narrative
H11: as the lot number for the device was provided, a review of the device history records was performed.The return of the sample is pending.The investigation of the reported event is currently underway.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
On (b)(6) 2025, a patient underwent an port placement procedure using the powerport slim ti.During the procedure, it was reported that the port could not draw back while the catheter was in the saline bowl, and air bubbles were observed despite multiple checks.The team verified all connections, changed syringes, and replaced the access needle, but the issue persisted.Consequently, the decision was made not to use the affected port and instead place a different port.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: one power port slim implantable port with attached catheter and a loaded tunneler were returned for sample evaluation.Gross, visual, microscopic visual, tactile and functional evaluations were performed.Port body showed multiple puncture access of the port septum.No visible defect was noted to the loaded tunneler after removal.Functional evaluation was performed and port body was patent to both infusion and aspiration without issue.No leaks were noted.Hydrostatic pressure was applied by clamping the distal end of the catheter while infusing to observe for leaks.No leaks were observed throughout test.Therefore, the investigation is unconfirmed for the reported suction and air in device issue as no suction problem was noted during sample evaluation.The definitive root cause could not be determined based upon available information.Labelling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.B5, g3, h6 (patient, component, 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.

• Brand Name: POWERPORT SLIM TI W 6FR CHRONOFLEX WO SP, INTER. KIT
• 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: 23777731
• Report Number: 3006260740-2025-09568
• Device Sequence Number: 9992820
• Product Code: LJT
• UDI-Device Identifier: 00801741026751
• UDI-Public: (01)00801741026751(11)250828(17)260930(10)REKU0508
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K072549
• 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): 12/19/2025

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 Expiration Date: 09/30/2026
• Device Catalogue Number: 1716001
• Device Lot Number: REKU0508
• 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: 11/19/2025
• Supplement Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2025
• 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