MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 TITANIUM LOW-PROFILE IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number	0605510
Medical Device Problem Codes	Peeled/Delaminated (1454); Tear, Rip or Hole in Device Packaging (2385); Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2025
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 was 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 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 a port placement procedure using chrono titanium port.During preparation of the procedure it was noted that, the packaging was stuck to the inner packaging, which caused the device to lose its sterility.There was no reported patient injury.
Additional Manufacturer Narrative
H11: additional information was received, and the file was reassessed for reportability and determined to be no longer reportable.Since an initial mdr was submitted, therefore, the file will remain assessed as a malfunction.G2, g3, h6 (device).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 a port placement procedure using chrono titanium port.During preparation of the procedure it was noted that, the packaging was stuck to the inner packaging, which caused the device to lose its sterility.There was no reported patient injury.
Additional Manufacturer Narrative
H11: additional information was received through the evaluation, and the file was reassessed for reportability.Based on the updated information the file will be assessed as a malfunction.Manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: one unsealed bard port titanium low profile implantable port kit was returned for sample evaluation.Visual evaluations were performed.The top product tyvek label was noted be not fully peeled from the main product tray.Seal transfer was noted on the peeled portion of tray.Manufacturing review was performed and the outer tray lid was apparently completely detached, seal transfer was observed through the edge of the tray, two tear-off labels were observed attached to the inner tray lid.Sealing transfer was also noted and "damaged inner packaging" is confirmed, this condition is related to the sealing process of the internal tray, the condition of the sample matches with the characteristics of a delamination failure, high temperature or high pressure possibly contributed to the delamination.Therefore, the investigation is confirmed for the reported packaging was stuck to the inner packaging and identified delamination issue.The cause of this condition related to manufacturing.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.B5, g3, h6 (device, 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.
Event or Problem Description
On (b)(6) 2025, a patient underwent a port placement procedure using titanium low profile port.During the preparation it was noted that the packaging was stuck to the inner packaging, which caused the device to lose its sterility.There was no reported patient injury.

• Brand Name: TITANIUM LOW-PROFILE IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 6F
• 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: 22574214
• Report Number: 3006260740-2025-05091
• Device Sequence Number: 9784609
• Product Code: LJT
• UDI-Device Identifier: 00801741025969
• UDI-Public: (01)00801741025969(11)250131(17)290430(10)REKN3046
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K050310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/03/2026

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: 0605510
• Device Lot Number: REKN3046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2025
• Supplement Date Received by Manufacturer: 01/06/2026; 02/02/2026
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 01/27/2026; 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2025
• 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