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

Catalog Number	6603880
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Fracture (1260); Material Separation (1562); Fitting Problem (2183); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that during a port placement procedure, the valve cuff on the port was allegedly broken and got separated.Reportedly, it could not be reattached.The procedure was completed with another device.There was no reported patient injury.
Event or Problem Description
It was reported that during a port placement procedure, the valve cuff on the port was allegedly broken and got separated.Reportedly, it could not be reattached.The procedure was completed with another device.There was no reported patient injury.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed and this lot met all release criteria.Investigation summary: one bardport mri l/p implantable port, one catheter, one cath-lock and few other kit components were returned for evaluation.Gross visual, microscopic and tactile evaluations were performed.A catheter segment was noted loaded on the 18g introducer needle bevel.The catheter segment measured approximately 1.9 cm in length.The catheter segment was removed from the introducer needle bevel for further observation.What appeared to be adhesive residue, was noted on the center portion of the catheter segment.Upon infusion, a leak was observed from the center portion/adhesive portion of the catheter segment while water exited the distal end of the catheter.Under microscopic observation, a partial circumferential break was noted on the catheter segment.The edges were noted to be uneven.The surface was noted to be granular in both regions; splits were noted on the border of both regions.The manufacturing site review states, visual inspection of the images showed one mri l/p implantable port, one catheter and one 20g introducer needle.A closer view showed slight residues of use throughout the sample, it was observed that a blue liquid was being infused through the catheter segment which revealed a leak in the section where the adhesive was placed, a partial fracture was observed in the body of the catheter segment where the adhesive was placed.Therefore the investigation is confirmed for the reported fracture.However, the investigation is inconclusive for the reported detachment, loss or failure to bond and material separation as no evidence of the reported events were noted during the sample evaluation.The 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, h4, 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.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed and this lot met all release criteria.Investigation summary: one bardport mri l/p implantable port, one catheter, one cath-lock and few other kit components were returned for evaluation.Gross visual, microscopic, tactile and functional evaluations were performed on the returned device.A catheter segment was noted loaded on the 18g introducer needle bevel.The catheter segment measured approximately 1.9cm in length.The catheter segment was removed from the introducer needle bevel for further observation.What appeared to be adhesive residue, was noted on the center portion of the catheter segment.Upon infusion, a leak was observed from the center portion/adhesive portion of the catheter segment while water exited the distal end of the catheter.Under microscopic observation, a partial circumferential break was noted on the catheter segment.The edges were noted to be uneven.The surface was noted to be granular in both regions; splits were noted on the border of both regions.The manufacturing site review states, a closer view showed slight residues of use throughout the sample, it was observed that a blue liquid was being infused through the catheter segment which revealed a leak in the section where the adhesive was placed, a partial circumferential break was observed under magnification, confirming the reported issue of a ¿fractured catheter¿.The fracture exhibited uneven edges, a granular surface texture, and striations throughout both regions.Therefore, the investigation is confirmed for the reported fracture, detachment and loss or failure to bond issues.And the investigation is unconfirmed for reported material separation issue.The 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.G3, h6 (component, result).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
A patient underwent for a port placement procedure using m.R.I.Low-profile implantable port, broviac single-lumen, 6.6f.It was reported that during a port placement procedure, the valve cuff on the port was allegedly broken and got separated.Reportedly, it could not be reattached.The procedure was completed with another device.There was no reported patient injury.

• Brand Name: M.R.I. LOW-PROFILE IMPLANTABLE PORT, BROVIAC 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: 21025364
• Report Number: 3006260740-2024-07811
• Device Sequence Number: 8329891
• Product Code: LJT
• UDI-Device Identifier: 00801741027413
• UDI-Public: (01)00801741027413(11)220809(17)250531(10)REGT5272
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K924250
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/10/2026

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: 05/31/2025
• Device Catalogue Number: 6603880
• Device Lot Number: REGT5272
• 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: 12/02/2024
• Supplement Date Received by Manufacturer: 06/24/2025; 04/10/2026
• Initial Report FDA Received Date: 12/27/2024
• Supplement Report FDA Received Date: 06/25/2025; 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2022
• 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