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

Model Number 1676301

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Itching Sensation (1943); Pain (1994)

Event Date 04/21/2021

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records will 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.(expiration date: 11/2021).Device not returned.

Event Description

It was reported that sometime post port placement, the patient experienced bleeding, pain and itching.The patient status was unknown.

Manufacturer Narrative

Manufacturing review: this is the first complaint reported to date for this product and lot, therefore a device history record review is not required.Investigation summary: the device was not returned for evaluation.Therefore, the reported pain, bleeding and itching around the access site issue cannot be confirmed.Based upon the available information a definitive root cause could not be determined.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.Expiry date: 11/2021.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 Description

It was reported that sometime post port placement, the patient experienced bleeding, pain and itching.The patient status was unknown.

• Brand Name: POWERPORT CLEARVUE SLIM IMPLANTABLE 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
• MDR Report Key: 11840476
• MDR Text Key: 251130799
• Report Number: 3006260740-2021-01883
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741110788
• UDI-Public: (01)00801741110788
• Combination Product (y/n): N
• PMA/PMN Number: K122899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/15/2021

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
• Device Operator: Health Professional
• Device Model Number: 1676301
• Device Catalogue Number: 1676301
• Device Lot Number: REET0979
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/21/2021
• Initial Date FDA Received: 05/18/2021
• Supplement Dates Manufacturer Received: 06/15/2021
• Supplement Dates FDA Received: 06/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other