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

Catalog Number 1716000

Device Problems Stretched (1601); Unraveled Material (1664); Deformation Due to Compressive Stress (2889); Physical Resistance/Sticking (4012)

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

Event Date 07/07/2023

Event Type  malfunction  

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 j-hook guidewire attached to an introducer needle was returned for evaluation.Functional, gross visual and microscopic visual evaluations were performed.Stretching was observed on the guidewire proximal to the j-hook and at the distal end of the guidewire.Bends were noted to the distal end of the guidewire and inner core wire was noted protruding out from the coils approximately 8.5cm from the distal tip.An attempt to retract the guidewire from the proximal end of the needle hub was made and guidewire inadvertently stretched.Therefore, the investigation is confirmed for the reported physical resistance and identified deformation, stretched and unraveled issues.Based on the measurements recorded during sample evaluation and applicable drawings, no measurements recorded could be confirmed to be out of tolerance.The definitive root cause could not be determined based upon available information.Labelling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiration date: 12/2024).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 : see h10.

Event Description

It was reported that during a port placement procedure, guidewire allegedly sticks in needle.There was no reported patient injury.

• Brand Name: POWERPORT SLIM IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 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: 18179478
• MDR Text Key: 328631645
• Report Number: 3006260740-2023-05270
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741026744
• UDI-Public: (01)00801741026744
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072549
• 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: 11/17/2023

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: 1716000
• Device Lot Number: REHQ1554
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2023
• Initial Date FDA Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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