MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 X-PORT ISP IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number	0607530
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260); Material Opacification (1426); Deformation Due to Compressive Stress (2889); Naturally Worn (2988)
Health Effect - Clinical Codes	Extravasation (1842); Swelling/ Edema (4577)
Date of Event	09/15/2023
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 records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.H10: d4 (expiration date: 03/2024).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 pending return.
Event or Problem Description
It was reported that sometime post a port placement, the patient allegedly experienced swelling of the neck with cervical edema of the port lodge.It was further reported that the healthcare personnel immediately ceased the infusion of the chemotherapy to prevent harm to the patient and a five-milliliter of the blood was aspirated to remove as much of the infused fluid.It was also reported that the catheter was allegedly opacified and ruptured, and confirmed a leak on the chamber path with extravasation of caelyx-type chemotherapy on the catheter.Furthermore, swelling and extravasation was caused due to perforation of the central pathway.Reportedly, ice pack was applied to reduce the product diffusion and topical corticosteroid was applied to treat swelling and extravasation.The port was removed with visualization of the breach in the catheter.The patient was reported to be stable.
Event or Problem Description
It was reported that sometime post a port placement, the patient allegedly experienced swelling of the neck with cervical edema of the port lodge.It was further reported that the healthcare personnel immediately ceased the infusion of the chemotherapy to prevent harm to the patient and a five-milliliter of the blood was aspirated to remove as much of the infused fluid.It was also reported that the catheter was allegedly opacified and ruptured, and confirmed a leak on the chamber path with extravasation of caelyx-type chemotherapy on the catheter.Furthermore, swelling and extravasation was caused due to perforation of the central pathway.Reportedly, ice pack was applied to reduce the product diffusion and topical corticosteroid was applied to treat swelling and extravasation.The port was removed with visualization of the breach in the catheter.The patient was reported to be 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 x-port isp implantable port attached to a catheter was received for evaluation.Visual, microscopic, tactile and functional evaluation were performed.The sample appeared to have residue and discoloration throughout.A partial compound break was noted approximately 10.5cm from the distal end of the cath-lock.Catheter wear was noted throughout the attached catheter and a complete circumferential break was noted on the distal end of the attached catheter.The edges of the partial compound break on the catheter were noted to be jagged.The surface was noted to be granular in one region: round and smooth in the other region.Upon infusion, a leak from the partial compound break was observed.Therefore, the investigation is confirmed for the reported fracture, fluid leak, opacification and identified wear and deformation issues.The definitive root cause could not be determined based upon available 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: 03/2024), g3, h6 (device).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: X-PORT ISP IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 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: 18019753
• Report Number: 3006260740-2023-04895
• Device Sequence Number: 7582181
• Product Code: LJT
• UDI-Device Identifier: 00801741026171
• UDI-Public: (01)00801741026171
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K022983
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2024

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: 0607530
• Device Lot Number: REFW0785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/28/2023
• Supplement Date Received by Manufacturer: 01/31/2024
• Initial Report FDA Received Date: 10/27/2023
• Supplement Report FDA Received Date: 02/02/2024
• 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: 53 YR
• Patient Sex: Female
• Patient Weight: 61 KG