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

Model Number	0603880
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that twenty-seven days post port implantation, the device was allegedly disconnect between the implantable port housing and the catheter.It was further reported that during the injection of the contrast medium, leakage of the latter to the housing-catheter interface and along the proximal third of the catheter was found.There was no reported patient injury.
Additional Manufacturer Narrative
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 as well as an image was provided for review.The investigation of the reported event is currently underway.(expiry date: 03/2026).
Event or Problem Description
It was reported that twenty-seven days post port implantation, the device was allegedly disconnect between the implantable port housing and the catheter.It was further reported that during the injection of the contrast medium, leakage of the latter to the housing-catheter interface and along the proximal third of the catheter was found.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one bard mri implantable port attached to a catheter was returned for evaluation.Gross, microscopic visual and functional testing were performed.Under microscopic observation.A complete circumferential break was noted to the catheter within the cath-lock and what appeared like a longitudinal break was also noted to the catheter.The distal catheter segment was not returned.The edges of the complete circumferential break appeared to be uneven.Striations were observed throughout.Upon infusion, a leak was observed from the cath-lock.In addition to the physical sample received for evaluation, two x-ray images were provided for review.The provided two chest x-rays focused on the right chest wall port and catheter.One image shows a ¿zoomed-in¿ view of the port during contrast administration.This demonstrates leakage of contrast near the port housing unit and proximal end of the port catheter.Therefore, the investigation is confirmed for the reported fluid leak and identified fracture issues.However, the investigation is inconclusive for the reported disconnection issue, as the clinical conditions cannot be replicated to confirm these failures.A definitive root cause for the reported failure could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 03/2026), g3, h6(device, method) h11: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: M.R.I. LOW-PROFILE 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: 13962715
• Report Number: 3006260740-2022-01029
• Device Sequence Number: 4782124
• Product Code: LJT
• UDI-Device Identifier: 00801741025846
• UDI-Public: (01)00801741025846
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K924250
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2022

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 Model Number: 0603880
• Device Catalogue Number: 0603880
• Device Lot Number: REFV2422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/04/2022
• Supplement Date Received by Manufacturer: 06/10/2022
• Initial Report FDA Received Date: 03/31/2022
• Supplement Report FDA Received Date: 06/13/2022
• 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