MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT ISP M.R.I. IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number	4808061
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504); Expulsion (2933); Migration (4003)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/17/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through the litigation process that sometime post a port placement, the port allegedly exposed and migrated.It was further reported that patient developed with infection.The current status of the patient is unknown.
Additional Manufacturer Narrative
H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.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 the litigation process that approximately nine months and fourteen days post a port placement, the port allegedly exposed and migrated.It was further reported that patient developed with infection and the infected port was removed.The current status of the patient was 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 (expiry date: 05/2021), g2, g3.H11: b3, b5, d4 (medical device lot number), h6 (result, conclusion).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.
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: the physical device was not returned for evaluation.Medical records were provided and reviewed.The patient underwent port placement procedure for right breast cancer without complications.Around six months later, patient presented to hospital for port check.Patient had blood drawn from the port and went okay and then saw some clear fluid through the pin hole the next day.The previous day, patient thought there was a scab on the port, but realized the port was exposed.The same day, patient underwent port removal procedure for history of infected port.Patient had a few episodes of port infections and other issues with the port and ultimately it healed and then subsequently became exposed.Incision was remade through the skin and the area that had been exposed was excised and sent as specimen.Electrocautery was used to expose the port, and it was then used to excise the port, sutures and a small capsule surrounding it.A figure of eight suture was placed around the catheter tract and clinched down as the port was removed.It was irrigated with copious amounts of antibiotic irrigation.Five days later, surgical pathology study of mediport and breast skin capsule report showed mediport removal.Fibrosis and inflammation consistent with previous excision site.Therefore, the investigation is confirmed for the reported material puncture, fluid leak and expulsion but kept inconclusive for the reported migration.Furthermore, it was confirmed the patient had infection.However, the relationship between the port and the alleged adverse event is unknown.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.H10: b5, d4 (expiration date: 05/2021), g3, h6 (device, method) h11: h6 (result, conclusion) 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 the litigation process that approximately nine months and fourteen days post a port placement procedure, the port allegedly had material puncture, fluid leak, exposed and migrated.It was further reported that patient developed with infection and the infected port was removed.The current status of the patient was unknown.

• Brand Name: POWERPORT ISP M.R.I. IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 8F
• 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: 19698603
• Report Number: 3006260740-2024-03541
• Device Sequence Number: 18060827
• Product Code: LJT
• UDI-Device Identifier: 00801741027338
• UDI-Public: (01)00801741027338(17)210531(10)REEQ0754
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K063377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• 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): 09/10/2024

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: 4808061
• Device Lot Number: REEQ0754
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2024
• Supplement Date Received by Manufacturer: 08/05/2024; 09/18/2024
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 09/02/2024; 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 49 YR
• Patient Sex: Female
• Patient Weight: 80 KG