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

Catalog Number	1718001
Medical Device Problem Codes	Unsealed Device Packaging (1444); Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a patient underwent for the port placement using powerport slim implantable.It was reported that during preparation of a port placement procedure the internal peel allegedly found external layer rendering it non-sterile.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 will be performed.The return of the sample is pending.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 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: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: one powerport slim implantable port kit was received for evaluation, and one photo was provided for review.Visual and dimensional observation was performed.The outer tyvek label appeared to be fully peeled, exposing the inner tray.The tyvek label on the inner tray appeared fully peeled, exposing the components.Both top tyvek label and product tyvek label were not attached to each other at any point throughout the trays.No stickiness was felt throughout the seal transfer portions of both trays.An attempt to join the top tyvek lid top right corner to the top right corner of the inner tray was performed.The small amounts of seal transfer noted on the top right corner of the inner tray appeared to match areas on the back side of the top tyvek lid corner.Small gaps could be seen in the mentioned areas.The back portion of the top tyvek of the outer tray was inspected with the front portion of the top tyvek of the inner tray for any signs of attachment and none were observed throughout.The photo shows the partially opened product tray in which both the outer tyvek label and inner tyvek labels were partially peeled.Therefore, the investigation is inconclusive for the reported inner layer of product tray stuck to outer layer while peeling issue as there are no signs of attachment between the two layers under laboratory conditions may not be representative of the condition of the device during use.A definitive root cause could not be determined based upon the provided 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 (device, method, result, conclusion).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
On (b)(6) 2025, a patient underwent for the port placement using powerport slim.It was reported that during preparation of a port placement procedure the internal peel allegedly found external layer rendering it non-sterile.There was no patient contact.

• Brand Name: POWERPORT SLIM IMPLANTABLE PORT, SINGLE-LUMEN CATHETER, 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: 22805049
• Report Number: 3006260740-2025-05888
• Device Sequence Number: 12721955
• Product Code: LJT
• UDI-Device Identifier: 00801741026799
• UDI-Public: (01)00801741026799(11)241114(17)260430(10)REJW1123
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K072215
• 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): 02/23/2026

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 Expiration Date: 04/30/2026
• Device Catalogue Number: 1718001
• Device Lot Number: REJW1123
• 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: 07/23/2025
• Supplement Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2024
• 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