MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 M.R.I. IMPLANTABLE PORT, HICKMAN SINGLE-LUMEN, 9.6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 0602660

Device Problems Difficult to Insert (1316); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 07/27/2021

Event Type  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.Medical records were not provided.Therefore, the investigation is inconclusive for the reported adverse event as no objective evidence was provided for review.Furthermore, clinical conditions alleged in the complaint cannot be confirmed.Based upon the available information, the definitive root cause is unknown.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 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 through the litigation process that sometime post a port placement, the patient allegedly experienced infection.The current status of the patent is unknown.

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: the physical device was not returned for evaluation.Medical records were provided.The medical record informed that the patient had a history of methicillin sensitive staphylococcus aureus bacteremia for the abort about three years prior to its removal and it was replaced.Then an bard implant port was placed for a patient to the left internal jugular vein due to the poor iv access.Attempts was made at the right anterior jugular vein with the help of ultrasound but it was unsuccessful and another atom was made over to the left internal jugular vein which was able to be accessed, for the guide way to be pleased and with the help of fluoroscopy it was confirmed the wire was into the right atrium at the first couple of attempts at passing the wire which was unsuccessful.However a glide wire was used to actually get through come on then an insertion was made in the left upper chest and the subcutaneous packet was created for the port the catheter was tunneled up to the left neck and it was cut to the appropriate length however it was difficult to get the actual catheter to the right position after several attempts.Then the blood was aspirated from the port and easily flushed with the saline further the incision was closed on the next day the patient had a granuloma at the site of broviac exit site which was removed after all the inflation was closed.Approximately three years later the patient was ill with the neck pain and also fever, the patient had chills nausea and vomiting.Assessed with a methicillin sensitive staphylococcus aureus bacteremia from the port and catheter the headache and stiffness was likely due to the bacteremia.The patient might have some degree of many meningismus of bacteremia.On the next day the skin examination revealed that the left just bored was surrendered by erythema.As the submitted medical records confirms the catheter had difficulty in insertion and the investigation was also confirms the same device malfunction.Additionally, it can be confirmed that the patient experienced bacteremia.However, the relationship to the port is unknown.Furthermore, the clinical condition alleged in the complaint cannot be confirmed.Based upon the available information, the definitive root cause is unknown.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiry date: 11/2024), g2, g3, h6 (method).H11: b3, b5, d4 (medical device lot number), h6 (patient, device, result).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.

Event Description

It was reported through the litigation process that during port placement via left internal jugular vein, it was difficult to insert the guidewire and catheter.It was further reported that sometime post a port placement, the patient allegedly developed bacteremia.Reportedly, the device was removed from the patient.The current status of the patent is unknown.

• Brand Name: M.R.I. IMPLANTABLE PORT, HICKMAN SINGLE-LUMEN, 9.6F
• 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: 19086007
• MDR Text Key: 339876109
• Report Number: 3006260740-2024-01627
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K873213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/10/2024

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: 0602660
• Device Lot Number: REEQ4182
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/22/2024
• Initial Date FDA Received: 04/11/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/29/2024
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 17 YR
• Patient Sex: Female