MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 M.R.I. HARD BASE IMPLANTABLE PORT, HICKMAN SINGLE-LUMEN, 6.6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number	0604580
Medical Device Problem Codes	Fracture (1260); Material Separation (1562); Migration (4003)
Health Effect - Clinical Code	Pulmonary Embolism (1498)
Date of Event	12/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that sometimes post a port placement, the catheter was allegedly ruptured and lodged in the pulmonary artery.Reportedly, the removed through hemodynamics and catheter was replaced.However, the current of the patient was unknown.
Additional Manufacturer Narrative
H10: 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.H11: 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.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: one bardport mri hard base implantable port attached to a catheter was returned for evaluation.Visual, microscopic, tactile and functional evaluations were performed on the returned device.A complete compound break was noted on the distal end of the attached catheter.The edges of the complete compound break on the attached catheter were noted to be uneven.The surface was noted to be granular.Therefore, the investigation is confirmed for the reported fracture and the material separation issues.However, the investigation inconclusive for the reported migration issue as the provided evidence do not confirm the migration of catheter.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.H11: 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
It was reported that sometimes post a port placement, the catheter was allegedly ruptured and lodged in the pulmonary artery.Reportedly, it was removed through hemodynamics and catheter was replaced.However, the current of the patient was unknown.

• Brand Name: M.R.I. HARD BASE IMPLANTABLE PORT, HICKMAN SINGLE-LUMEN, 6.6F
• 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: 21292160
• Report Number: 3006260740-2025-00280
• Device Sequence Number: 20729327
• Product Code: LJT
• UDI-Device Identifier: 00801741025877
• UDI-Public: (01)00801741025877(11)231221(17)280331(10)REHW1839
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K873213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0604580
• Device Lot Number: REHW1839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2025
• Supplement Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 02/03/2025
• Supplement Report FDA Received Date: 06/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown