MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT CLEARVUE SLIM IMPLANTABLE PORT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	1618001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cellulitis (1768); Sepsis (2067)
Date of Event	08/12/2019
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 not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 10/2020).Device not returned.
Event or Problem Description
It was reported through the litigation process that an implantable port was implanted successfully.The device was removed.The patient was diagnosed with line sepsis and initial encounter of cellulitis of chest wall; however, the current status of the patient is unknown.
Event or Problem Description
It was reported through the litigation process that an implantable port was implanted successfully.The device was removed.The patient was diagnosed with line sepsis and initial encounter of cellulitis of chest wall; however, the current status of the patient is 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: the sample was not returned for evaluation, however, a medical record review was performed.The investigation is confirmed for the reported cellulitis and sepsis issue.According to the medical record, five days post port placement, the patient was diagnosed with line sepsis and initial encounter of cellulitis of chest wall.On the same day, an attempt was made to retrieve the right chest port from the patient¿s body.The catheter was isolated and removed from the vein.Also, the port was freed from the surrounding soft tissues with blunt dissection and removed.The wound was covered with a sterile dressing.Further, there was no evidence to confirm that the reported issue was happened due to the port placement.A 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: 10/2020),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: POWERPORT CLEARVUE SLIM IMPLANTABLE PORT
• 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
• MDR Report Key: 12099651
• Report Number: 3006260740-2021-02521
• Device Sequence Number: 3713279
• Product Code: LJT
• UDI-Device Identifier: 00801741026492
• UDI-Public: (01)00801741026492
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K122899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2021

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: 1618001
• Device Catalogue Number: 1618001
• Device Lot Number: REDS3787
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/07/2021
• Supplement Date Received by Manufacturer: 08/10/2021
• Initial Report FDA Received Date: 07/01/2021
• Supplement Report FDA Received Date: 08/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 56 YR