MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT ISP MRI 6F CHRONW/OS; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 8806061

Device Problems Difficult to Flush (1251); Suction Problem (2170); Blocked Connection (2888)

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

Event Date 09/04/2022

Event Type  malfunction  

Manufacturer Narrative

H10: 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.However, a photo was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 01/2023).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 sometime post a port placement procedure via right internal jugular vein, the port body allegedly was not accessible when flushing the catheter.It was further reported that the suction was allegedly not smooth.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: the sample was not returned for evaluation.One electronic photo was provided for review.The photo shows one unsealed sample tray containing one power port attached to the catheter, one vein pick, one dilator sheath, one tunneler with end cap and one guidewire along with the hoop.Therefore the investigation is inconclusive for the reported difficult to flush and suction issue as the exact circumstances at the time of the reported event was unknown and cannot be verified from the provided photos.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 (expiry date: 01/2023), 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.H3 other text : device not returned.

Event Description

It was reported that two days post a port placement procedure via right internal jugular vein, the port body allegedly was not accessible when flushing the catheter.It was further reported that the suction was allegedly not smooth.There was no reported patient injury.

• Brand Name: POWERPORT ISP MRI 6F CHRONW/OS
• 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: 18382824
• MDR Text Key: 331197542
• Report Number: 3006260740-2023-05822
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741098963
• UDI-Public: (01)00801741098963
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K063377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/11/2024

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: 8806061
• Device Lot Number: REFP3332
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2023
• Initial Date FDA Received: 12/22/2023
• Supplement Dates Manufacturer Received: 02/19/2024
• Supplement Dates FDA Received: 03/15/2024
• 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