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

Catalog Number	0606100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Bacteremia (4846)
Date of Event	07/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not requested as the lot number reported as unknown.Investigation summary: the physical device was not returned for evaluation.No medical record were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.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.
Event or Problem Description
It was reported through litigation process that sometime post a port placement, the patient allegedly developed infection.However, the current status of the patient is unknown.
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 device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.H10: d4 (expiration date: 04/2025), g2, g3.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.
Event or Problem Description
It was reported through litigation process that one year and twenty-eight days post port placement procedure, the patient allegedly developed bacteremia.The device was removed from the patient.However, the current status of the patient is unknown.
Event or Problem Description
It was reported through litigation process that one year and twenty-eight days post port placement procedure, the patient allegedly developed bacteremia.The device was removed from the patient.However, the current status of the patient is unknown.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not requested as the lot number reported as unknown.Investigation summary: the physical device was not returned for evaluation.The medical records allege that, for a patient with history of t-cell acute lymphoblastic leukemia placement of port was performed.The left subclavian vein was cannulated with modified seldinger technique, and the position centrally confirmed with fluoro.An incision was made around the wire and a pocket created in the subcutaneous pocket inferior to the incision.The port was secured in the pocket.The catheter was cut to an appropriate length and a peel-away introducer used to place the catheter into the central venous system with the final position confirmed by fluoroscopy where there was good blood flow and return.The catheter was flushed with heparinized saline solution.The subcutaneous tissues and skin were closed with absorbable suture.Approximately one year one month later, the patient developed fever of unknown cause and routine blood culture was performed.Ten days after, removal of port was performed as the patient developed bacteremia resistant to therapy.The port was de accessed.The previous port pocket incision was reopened with a blade scalpel and deepened with electrocautery down to the port and the tubing.The tubing was removed from the intravascular space.The port was removed from the port pocket.There were no sutures to remove and there was no evidence of purulence within the port pocket.The soft tissues were closed with suture.Therefore, the investigation is inconclusive as no objective evidence for the reported deficiency with the port in the submitted medical record review.Additionally, it can be confirmed that the patient experienced bacteremia and infection.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.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.

• Brand Name: TITANIUM 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: 19247071
• Report Number: 3006260740-2024-02161
• Device Sequence Number: 12409653
• Product Code: LJT
• UDI-Device Identifier: 00801741026041
• UDI-Public: (01)00801741026041
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K050310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/09/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 0606100
• Device Lot Number: REEY3357
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/19/2024
• Supplement Date Received by Manufacturer: 06/11/2024; 07/09/2024
• Initial Report FDA Received Date: 05/06/2024
• Supplement Report FDA Received Date: 06/24/2024; 07/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/08/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 3 YR
• Patient Sex: Male