MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GLIDE PATH HEMODIALYSIS CATH; DIALYSIS CATHETER

Catalog Number 6393230

Device Problems Contamination (1120); Device Contamination with Chemical or Other Material (2944)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/03/2020

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 device has not been returned to the manufacturer for evaluation; however, photos have been provided.The investigation of the reported event is currently underway.Expiry date (01/2021).

Event Description

It was reported that sometime post dialysis catheter implant, the device allegedly had white material accumulation in external tubes.There was no reported patient injury.

Event Description

It was reported that sometime post dialysis catheter implant, the device allegedly had white material accumulation in external tubes.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: the device history record review was performed for the reported lot number and this lot meets all release criteria.The manufacturing review did not indicate any possible manufacturing issue that could be related to the reported event.Investigation summary: the device was not returned for evaluation, however, six electronic photos were provided for review.The investigation is confirmed for white material accumulation within the catheter, as the photo evaluation revealed whitish particulate within the extension legs and particularly on the venous lumen.A 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:01/2021),g4.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 dialysis catheter implant, the device allegedly had a white material accumulation in external tubes.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: the device history record review was performed for the reported lot number and this lot meets all release criteria.The manufacturing review did not indicate any possible manufacturing issue that could be related to the reported event.Investigation summary: one gidepath d/l catheter was returned for evaluation and six electronic photos were provided for review.The investigation is confirmed for white material accumulation within the catheter, as the photo evaluation revealed whitish particulate within the extension legs and particularly on the venous lumen and unknown fibrous material was also observed on the extension legs of the catheter during sample evaluation.A 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.Instructions for use indicates: ¿¿ alcohol should not be used to lock, soak or de-clot polyurethane dialysis catheters because alcohol is known to degrade polyurethane catheters over time with repeated and prolonged exposure.¿ ¿care and maintenance the care and maintenance of the catheter requires well trained, skilled personnel following a detailed protocol.The protocol should include a directive that the catheter is not to be used for any purpose other than the prescribed therapy.Accessing catheter, cap changes, dressing changes: ¿ experienced personnel; ¿ use aseptic technique; proper hand hygiene; ¿ clean gloves to access catheter and remove dressing and sterile gloves for dressing changes; ¿ surgical mask (1 for the patient and 1 for the healthcare professional); ¿ catheter exit site should be examined for signs of infection and dressings should be changed at each dialysis treatment.¿ catheter luer-lock connectors with end caps attached should be soaked for 3 to 5 minutes in povidone iodine and then allowed to dry before separation.¿ carefully remove the dressing and inspect the exit site for inflammation, swelling and tenderness.Notify physician immediately if signs of infection are present.¿ ¿post dialysis.Use aseptic technique (as outlined above).1.Flush arterial and venous lumens with a minimum of 10 ml of sterile saline.Warning: to avoid damage to vessels and viscus, infusion pressures must not exceed 25 psi (172 kpa).The use of a 10 ml or larger syringe is recommended because smaller syringes generate more pressure than larger syringes.2.Inject heparin solution into both the arterial and venous lumens of the catheter.The appropriate heparin solution concentration and flushing frequency should be based on hospital protocol.Heparin solution of 1,000 to 5,000 units/ml has been found to be effective for maintaining the patency of hemodialysis and apheresis catheters.When injecting heparin solution, inject quickly and clamp extension while under positive pressure.Heparin solution volume to lock each lumen must be equal to the priming volume of each lumen.Priming volumes are marked on each lumen.3.Clean catheter luer-lock connectors per hospital protocol.Attach sterile end caps to both the arterial and the venous clamping extension pieces.Warning: to prevent systemic heparinization of the patient, the heparin solution must be aspirated out of both lumens immediately prior to using the catheter.In most instances, no further heparin solution injection is necessary for 48-72 hours, provided the catheter has not been aspirated or flushed.¿.H10: d4(expiry date:01/2021),g3.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.

• Brand Name: GLIDE PATH HEMODIALYSIS CATH
• Type of Device: DIALYSIS CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10182896
• MDR Text Key: 196059811
• Report Number: 3006260740-2020-02184
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00801741138508
• UDI-Public: (01)00801741138508
• Combination Product (y/n): N
• PMA/PMN Number: K051748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6393230
• Device Lot Number: REDQ2914
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2021
• Date Manufacturer Received: 07/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1