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 Codes	Fracture (1260); Material Separation (1562); Migration (4003)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history record is currently being performed.The device has been returned to the manufacturer for evaluation.However, a photo and an image 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 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 that sometime post a port placement, the catheter allegedly took an odd direction at the level of the clavicle and attempts at straightening it were unsuccessful, but the catheter functioned well without any difficulty.It was further reported that two years, two months and twenty-six days post the port placement, in the process of removing the port, the connector that holds the catheter onto the port body was allegedly found to be fractured lengthwise in half and was not intact.Furthermore, the pieces were separate from each other but held within a fibrous capsule, and a small broken piece had moved slightly.Reportedly, the capsule was grossly dissected, and the pieces were removed with forceps.The current status of the patient was unknown.
Event or Problem Description
It was reported that sometime post a port placement, the catheter allegedly took an odd direction at the level of the clavicle and attempts at straightening it were unsuccessful, but the catheter functioned well without any difficulty.It was further reported that two years, two months and twenty-six days post the port placement, in the process of removing the port, the connector that holds the catheter onto the port body was allegedly found to be fractured lengthwise in half and was not intact.Furthermore, the pieces were separate from each other but held within a fibrous capsule, and a small broken piece had moved slightly.Reportedly, the capsule was grossly dissected, and the pieces were removed with forceps.The current status of the patient was unknown.
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 bardport titanium l/p implantable port, one catheter segment, and one cath-lock in two segments were received for evaluation.One electronic photo and image were provided for review.Gross, visual, microscopic, tactile and functional testing were performed on the returned device.One cathlock into two segments was noted.Tool damage was noted to both segments of the cath-lock.Therefore, the investigation is confirmed for the reported cathlock fracture and material separation.However, the investigation is inconclusive for the reported migration issue as the exact circumstances at the time of reported event is unknown.A definitive root cause could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiration date: 04/2025), g3, h6 (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: 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: 19413539
• Report Number: 3006260740-2024-02642
• Device Sequence Number: 15640101
• Product Code: LJT
• UDI-Device Identifier: 00801741026041
• UDI-Public: (01)00801741026041
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K050310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2024

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/02/2024
• Supplement Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 05/29/2024
• Supplement Report FDA Received Date: 07/05/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 13 YR
• Patient Sex: Female
• Patient Weight: 49 KG
• Patient Ethnicity: Non Hispanic