MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWER PORT MRI ISP, 8 FR GROSHONG, INT WO SP, SL; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 8808561

Device Problems No Display/Image (1183); Inadequate Instructions for Healthcare Professional (1319); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/02/2023

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history records could not 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.The information provided 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 during a port placement procedure, the healthcare professional was poorly reported of the presence of a stylet catheter inside the kit.However, physician noted the lack of radiological detection of the stylet inside the catheter.It was further reported that the implantation was carried out under scoping and the x-ray revealed that the stylet was allegedly not visible after implantation.Reportedly, the stylet was removed without further complications.The procedure was completed without any consequences for the patient.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the physical device was not returned for evaluation, two photos were provided for review.The photo shows the product material#, flushing hub attached to the catheter in which a cathlock is attached in the middle of the catheter.Also, a warning tag with "flush catheter prior to use" was noted hung in the catheter.Therefore, the investigation is confirmed for the reported improper procedure issue as the port was implanted along with the stylet.However, the investigation is inconclusive for the reported inadequate instruction for healthcare professional and no display issues, as no objective evidence was provided for review.The definitive root cause could not be determined based upon available 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.H11: section a through f ¿ the information provided 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.H3 other text : device not returned.

Event Description

It was reported that during a port placement procedure, the healthcare professional was poorly reported of the presence of a stylet catheter inside the kit.However, physician noted the lack of radiological detection of the stylet inside the catheter.It was further reported that the implantation was carried out under scoping and the x-ray revealed that the stylet was allegedly not visible after implantation.Reportedly, the stylet was removed without further complications.The procedure was completed without any consequences for the patient.There was no reported patient injury.

• Brand Name: POWER PORT MRI ISP, 8 FR GROSHONG, INT WO SP, SL
• 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: 16665496
• MDR Text Key: 312631988
• Report Number: 3006260740-2023-01127
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741099007
• UDI-Public: (01)00801741099007
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K063377
• 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: 07/25/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 8808561
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2023
• Initial Date FDA Received: 04/03/2023
• Supplement Dates Manufacturer Received: 07/25/2023
• Supplement Dates FDA Received: 07/26/2023
• 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