MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 UNKNOWN LOW ARTIFACT POWER PORT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number UNK LOW ARTIFACT POWER PORT

Device Problems Blocked Connection (2888); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bacterial Infection (1735)

Event Date 01/17/2023

Event Type  Injury  

Event Description

It was reported that approximately one month post port placement, the patient allegedly experienced symptoms of fever, headache and was identified with open sores at the site of the port placement.It was further reported that the patient was allegedly tested positive for staph infection and the cause of the infection was determined to be the port.Reportedly, antibiotics were prescribed.The port was removed.The current status of the patient is unknown.

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history records could not be performed.The device has not been returned to the manufacturer for evaluation.However, a photo was provided for review.The investigation of the reported event is currently underway.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not requested as the lot number reported as unknown.Investigation summary: the physical device was not returned for evaluation.Three electronic photos were provided for review.The photos shows bruises like red marks and pus on the skin of the patient and one powerport patient card.However, the investigation is inconclusive for the reported blocked connection and infection as it is unknown whether the red marks on the patient skin was caused by the device.Furthermore, the clinical conditions alleged in the complaint cannot be confirmed.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.

Event Description

It was reported that approximately one month post port placement, the patient allegedly experienced symptoms of fever, headache and was identified with open sores at the site of the port placement.It was further reported that the port was unable to be accessed and the patient allegedly tested positive for staph infection and the cause of the infection was determined to be the port.Reportedly, antibiotics were prescribed.The port was removed.The current status of the patient is unknown.

• Brand Name: UNKNOWN LOW ARTIFACT POWER PORT
• Type of Device: 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: 16359848
• MDR Text Key: 309366557
• Report Number: 3006260740-2023-00417
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/30/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK LOW ARTIFACT POWER PORT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/17/2023
• Initial Date FDA Received: 02/12/2023
• Supplement Dates Manufacturer Received: 04/05/2023
• Supplement Dates FDA Received: 04/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female