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

Catalog Number 0603880CE

Device Problems Disconnection (1171); Fracture (1260); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Migration (4003)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/01/2024

Event Type  Injury  

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the m.R.I.Low-profile implantable port, hickman single-lumen, 6.6f that are cleared in the us.The pro code and 510 k number for the m.R.I.Low-profile implantable port, hickman single-lumen, 6.6f are identified in d2 and g4.H10: as the lot number for the device was provided, a review of the device history records will be performed.The device has not been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiration date: 04/2025).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 Description

It was reported that four months seventeen days post a port placement, the chamber and the catheter were allegedly disconnected.It was further reported that the fragment of the port was allegedly found between the superior vena cava and the right atrium.Reportedly the catheter fragment was removed through surgical intervention.The port was removed and replaced.The current status of the patient is unknown.

Event Description

It was reported that sometime post a port placement, the staff allegedly failed to carry out flushing the device for thirty days.It was further reported that four months and seventeen days post the port placement, the chamber and the catheter were allegedly found to be disconnected.Furthermore, fragments of the port were allegedly found between the superior vena cava and the right atrium.Reportedly, the catheter fragment was removed through surgical intervention and the port was removed and replaced.The current status of the patient is unknown.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the m.R.I.Low-profile implantable port, hickman single-lumen, 6.6f that are cleared in the us.The pro code and 510 k number for the m.R.I.Low-profile implantable port, hickman single-lumen, 6.6f are identified in d2 and g4.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: the physical device was not returned for evaluation.Two photos were provided for review.The photo shows a catheter, cathlock and port.Therefore the investigation is inconclusive for the reported fracture, material separation and migration issues as the provided evidence was not sufficient enough to confirm the reported issues.However the investigation is confirmed for the reported improper procedure issue as the port was not flushed for thirty days.Although the definitive root cause for the reported fracture, material separation and migration issues could not be determined based upon available information, the root cause for improper flushing issue was noted to be use error.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.Instruction for use states that: flushing volumes: when port not in use- 5 ml sterile normal saline every 28 days.H10: b5, d4 (expiration date: 04/2025), g3, h6 (method) h11: h6 (device, result, conclusion) 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.

• Brand Name: M.R.I. LOW-PROFILE IMPLANTABLE PORT, HICKMAN SINGLE-LUMEN, 6.6F
• Type of Device: 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: 18920445
• MDR Text Key: 337853412
• Report Number: 3006260740-2024-01145
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K924250
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/18/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 0603880CE
• Device Lot Number: REFQ3592
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2024
• Initial Date FDA Received: 03/18/2024
• Supplement Dates Manufacturer Received: 05/23/2024
• Supplement Dates FDA Received: 05/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention