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	1618070
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2026, a patient was prepped for a port placement procedure using the powerport clearvue slim.During the preparation for use, the outer package cover was reportedly adhered to the inner cover containing the port, resulting in both covers opening simultaneously when the package was opened.Since the inside of the package was stuck to the outside of the package, when they opened it up, it all flew everywhere which caused it to fall on the ground and compromise its sterility.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 device has been returned to the manufacturer for evaluation.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.

• 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: michael gaffney ; 800 w. rio salado pkwy; tempe, AZ 85281 ; +1(480)303-2689
• MDR Report Key: 50894168
• Report Number: 3006260740-2026-07010
• Device Sequence Number: 14952719
• Product Code: LJT
• UDI-Device Identifier: 00801741026508
• UDI-Public: (01)00801741026508
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K122899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/03/2026

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: 1618070
• Device Lot Number: RELQ0462
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/10/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/25/2026
• 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