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

Model Number	0606100
Medical Device Problem Codes	Disconnection (1171); Fracture (1260); Material Separation (1562); Detachment of Device or Device Component (2907); Migration (4003)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The device has not been returned to the manufacturer for evaluation.However, photos and an image were provided for review.The investigation of the reported event is currently underway.(expiry date: 08/2022).Device not returned.
Event or Problem Description
It was reported that one year post catheter placement procedure and upon x-ray examination, the catheter of the device was allegedly found to be fractured.It was further noted that a part of the catheter had migrated to the pulmonary artery.The device was removed by additional surgery.The current status of the patient is unknown.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the sample was not returned for evaluation.One electronic photo and one medical image was provided for review.The investigation is confirmed for the reported fracture, material separation issues as a complete longitudinal break was noted on the cath-lock and the cath-lock was separated into two segment in the provided photo.Further, the investigation is confirmed for the reported migration and identified disconnection issues as the catheter was found disconnected and migrated along the chest to the left shoulder in the provided medical image.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.H10: d4 (expiry date: 08/2022).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.H3 other text : device not returned.
Event or Problem Description
It was reported that approximately eight months post catheter placement procedure and upon x-ray examination, the catheter of the device was allegedly found to be fractured and separated.It was further noted that a part of the catheter had migrated to the pulmonary artery.The device was removed by additional surgery.The current status of the patient is unknown.

• 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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12695881
• Report Number: 3006260740-2021-04539
• Device Sequence Number: 1389348
• Product Code: LJT
• UDI-Device Identifier: 00801741026041
• UDI-Public: (01)00801741026041
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K050310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2021

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 Model Number: 0606100
• Device Catalogue Number: 0606100
• Device Lot Number: REBW0461
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/29/2021
• Supplement Date Received by Manufacturer: 12/08/2021
• Initial Report FDA Received Date: 10/26/2021
• Supplement Report FDA Received Date: 12/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2017
• 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 Sex: Unknown