MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT CLEARVUE SLIM IMPLANTABLE PORT, CHRONOFLEX, 6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 5676300

Device Problem Component Misassembled (4004)

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

Event Date 02/12/2024

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 device has been returned to the manufacturer for evaluation.However, a photo was provided for review.The investigation of the reported event is currently underway.D4 (expiration date: 07/2025).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 during a port placement procedure, the guidewire was allegedly found to be loaded in the device backwards.The procedure was completed using another device.There was no reported patient injury.

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: one powerport kit along with all the components were returned for sample evaluation and one photo was provided for review.The samples appeared to be clean.The j-tip guidewire was received in its correct loaded condition (j-tip exposed at the end of the guidewire straightener).No anomalies were noted in photo review as well.Therefore, the investigation is unconfirmed for the reported guidewire backward loaded issue.The definitive root cause could not be determined based upon available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiration date: 07/2025), g3, h6 (method).H11: b5, 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.

Event Description

It was reported that during a port placement procedure, the guidewire was allegedly found to be loaded in the device backwards.The procedure was completed using another guidewire.There was no reported patient injury.

• Brand Name: POWERPORT CLEARVUE SLIM IMPLANTABLE PORT, CHRONOFLEX, 6F
• 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: 19102985
• MDR Text Key: 340845630
• Report Number: 3006260740-2024-01745
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741110771
• UDI-Public: (01)00801741110771
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5676300
• Device Lot Number: REHU3372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2024
• Initial Date FDA Received: 04/14/2024
• Was Device Evaluated by Manufacturer?: No
• 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