MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 HEMOSTAR; DIALYSIS CATHETERS

Catalog Number UNK HEMOSTAR

Device Problems Material Discolored (1170); Material Opacification (1426); Stretched (1601); Deformation Due to Compressive Stress (2889); Material Deformation (2976); Material Protrusion/Extrusion (2979)

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

Event Date 03/01/2022

Event Type  malfunction  

Event Description

It was reported that during a dialysis catheter placement, the device material allegedly discolored and distortion.There was no reported patient injury.

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history records could not be 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.

Event Description

It was reported that during a dialysis catheter placement, the device material allegedly discolored and distortion.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the physical sample was not returned for evaluation.One electronic photo was provided for review.The investigation is confirmed for the reported catheter emulsification, discoloration and identified material protrusion and stretched issues as, both the extension legs were noted to be emulsified, discolored and bulged.Clamps were noted on the extension legs and appears discolored.Further, milky white opacification was noted on the area of protrusion of both the extension legs proximal to the bifurcation.A definitive root cause could not be determined based upon the 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.The current instructions for use states, warning: acetone and polyethylene glycol (peg)-containing ointments can cause failure of this device and should not be used with polyurethane catheters.Chlorhexidine patches or bacitracin zinc ointments (e.G., polysporin ointment) are the preferred alternative.Alcohol or alcohol-containing antiseptics (such as chlorhexidine) may be used to clean the catheter/skin site; however, care should be taken to avoid prolonged or excessive contact with the solution(s).Solutions should be allowed to completely dry before applying dressing.Warning: alcohol should not be used to lock, soak or declot 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.Exit site cleaning: povidone iodine, dilute aqueous sodium hypochlorite solution, chlorhexidine gluconate 4%, or chlorhexidine gluconate 2% solution are the suggested antiseptics to use.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.

Manufacturer Narrative

Manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the physical sample was not returned for evaluation, one electronic photo was provided for review.The investigation is confirmed for the reported catheter opacification, discoloration and identified bulged, kinking and consequent thinning of extension legs issues as, both the extension legs were noted to be kinked, protruded, discolored and bulged.Further, milky white opacification was noted on the bulged area of both the extension legs just proximal to the bifurcation.However, the investigation is unconfirmed for the reported catheter deformation issue as bulged and consequent thinning were identified in the provided photo.A definitive root cause could not be determined based upon the 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.The current instructions for use states, warnings: warning: alcohol or alcohol-containing antiseptics (such as chlorhexidine) may be used to clean the catheter/skin site; however, care should be taken to avoid prolonged or excessive contact with the solution(s).Solutions should be allowed to completely dry before applying dressing.Care and maintenance: 1.Povidone iodine, dilute aqueous sodium hypochlorite solution, chlorhexidine gluconate 4%, or chlorhexidine gluconate 2% solution are the suggested antiseptics to use.Warning: acetone and peg-containing ointments can cause failure of this device and should not be used with polyurethane catheters.Chlorhexidine patches or bacitracin zinc ointments (e.G., polysporin* ointment) are the preferred alternative.2.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.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 during a dialysis catheter placement, the device material allegedly discolored and distortion.There was no reported patient injury.

• Brand Name: HEMOSTAR
• Type of Device: DIALYSIS CATHETERS
• 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: 15062942
• MDR Text Key: 300908092
• Report Number: 3006260740-2022-02787
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: UNKNOWN
• 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,Followup
• Report Date: 11/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HEMOSTAR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2022
• 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