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

Model Number	0602230
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260); Material Separation (1562)
Health Effect - Clinical Codes	Extravasation (1842); Embolism/Embolus (4438); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer.The investigation of the reported event is currently underway.Medical device: expiry date: 03/2026.
Event or Problem Description
It was reported that approximately one month post port placement procedure via internal jugular vein, the catheter was allegedly separated and had break.It was further reported that the device allegedly had leakage at proximal end.Reportedly, patient experienced extravasation.The current status of the patient is stable.
Additional Manufacturer Narrative
H10: additional information was received and the file was reassessed for reportability and determined to be reportable as serious injury.H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer.The investigation of the reported event is currently underway.H10: b5, d4 (expiry date: 03/2026).H11: section a through f ¿ the information provide 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 that approximately one month post port placement procedure via internal jugular vein, the catheter was allegedly separated and had break.It was further reported that the device allegedly had leakage at proximal end.Reportedly, catheter was allegedly embolized and the patient experienced extravasation.The current status of the patient is stable.
Event or Problem Description
It was reported that fifty five days post port placement procedure via internal jugular vein, the catheter was allegedly separated and had break.It was further reported that the device allegedly had leakage at proximal end.Reportedly, catheter was allegedly embolized and the patient experienced extravasation.The current status of the patient is stable.
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 titanium low profile implantable port attached to a catheter were returned for evaluation.Functional, gross visual, tactile and microscopic visual evaluations were performed.The investigation is confirmed for the reported fracture and fluid leak issues, as the proximal end of the attached catheter was observed to have three splits.The investigation is unconfirmed for the reported material separation issues, as no complete separation was noted on the catheter.A definitive root cause could not be determined based upon the 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 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 : see h10.

• Brand Name: TITANIUM IMPLANTABLE PORT, HICKMAN SINGLE-LUMEN, 9.6F
• 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: 15571555
• Report Number: 3006260740-2022-03941
• Device Sequence Number: 20352863
• Product Code: LJT
• UDI-Device Identifier: 00801741025563
• UDI-Public: (01)00801741025563
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K050310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/21/2022

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: 0602230
• Device Catalogue Number: 0602230
• Device Lot Number: REFV1377
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/13/2022
• Supplement Date Received by Manufacturer: 09/21/2022; 12/05/2022
• Initial Report FDA Received Date: 10/10/2022
• Supplement Report FDA Received Date: 10/19/2022; 12/10/2022
• 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: Life Threatening
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 55 KG