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

Model Number 1668362

Device Problems Unsealed Device Packaging (1444); Defective Component (2292); Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/14/2020

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The sample was not returned to the manufacturer for evaluation; however, photo was provided for review.The investigation of the reported event is currently underway.(expiry date: 07/2021).Device not returned.

Event Description

It was reported that prior to a procedure, the connector was not connected and flush did not seal.There was no reported patient injury.

Event Description

It was reported that prior to a procedure, the connector was not connected and flush did not seal.There was no patient contact.

Manufacturer Narrative

H10: the file was reassessed for reportability and determined to be no longer reportable.Since an initial mdr was submitted, therefore, the file will remain assessed as a malfunction.H10: manufacturing review: a complaint history review was performed.This is the first complaint reported for this product/lot number combination.A device history record review is not required.However, the device history records were reviewed and there was nothing found to indicate there was a manufacturing related cause for these reports.Investigation summary: the sample was not returned for evaluation.One electronic photo was provided for review.The investigation is inconclusive for the reported defective component and connection issues, as the provided photo is not sufficient enough to confirm the reported issues.The 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: 07/2021).H11: 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.H3 other text : device not returned.

• Brand Name: POWERPORT CLEARVUE ISP IMPLANTABLE PORT 8F CHRONOFLEX
• 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: 11130029
• MDR Text Key: 225563756
• Report Number: 3006260740-2020-21207
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741110740
• UDI-Public: (01)00801741110740
• Combination Product (y/n): N
• PMA/PMN Number: K063377
• 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: 07/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1668362
• Device Catalogue Number: 1668362
• Device Lot Number: REEU0735
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other