MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 TITANIUM LOW-PROFILE IMPLANTABLE PORT, BROVIAC SINGLE-LUMEN, 6.6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number 0602190

Device Problems Entrapment of Device (1212); Fracture (1260); Difficult to Remove (1528); Material Separation (1562)

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

Event Date 05/16/2023

Event Type  malfunction  

Event Description

It was reported that approximately three years and one month post-port placement, the port allegedly broke away from the catheter during the attempt to remove the device.It was further reported that the port was easily dissected free of the capsule.It was also reported that the catheter was allegedly fixed at the subclavian vein entry site and was dissected free of surrounding tissue down to the vein under the clavicle.However, the external aspect of the catheter was noted to be changed from smooth to textured, likely related to calcifications, adhesion, or ingrowth within the vein.Reportedly, the catheter was unable to be pulled out with vein tenting upon traction, and it was decided to leave the internal catheter in place due to the risk of vein injury or hemorrhage.The external catheter and the subcutaneous port were removed.There was no reported patient 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.Expiry date: 04/2023.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.

Event Description

It was reported that approximately three years and one month post-port placement, the port allegedly broke away from the catheter during the attempt to remove the device.It was further reported that the port was easily dissected free of the capsule.It was also reported that the catheter was allegedly fixed at the subclavian vein entry site and was dissected free of surrounding tissue down to the vein under the clavicle.However, the external aspect of the catheter was noted to be changed from smooth to textured, likely related to calcifications, adhesion, or ingrowth within the vein.Reportedly, the catheter was unable to be pulled out with vein tenting upon traction, and it was decided to leave the internal catheter in place due to the risk of vein injury or hemorrhage.The external catheter and the subcutaneous port were removed.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 physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.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: 04/2023).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: TITANIUM LOW-PROFILE IMPLANTABLE PORT, BROVIAC SINGLE-LUMEN, 6.6F
• 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: 17150483
• MDR Text Key: 318096433
• Report Number: 3006260740-2023-02493
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741025549
• UDI-Public: (01)00801741025549
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/25/2023

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 Model Number: 0602190
• Device Catalogue Number: 0602190
• Device Lot Number: REDV2237
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/22/2023
• Initial Date FDA Received: 06/19/2023
• Supplement Dates Manufacturer Received: 09/06/2023
• Supplement Dates FDA Received: 09/08/2023
• 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
• Patient Sex: Male