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

Catalog Number 5833730

Device Problems Material Discolored (1170); Material Opacification (1426); Stretched (1601); Material Deformation (2976); Material Protrusion/Extrusion (2979)

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

Event Date 11/14/2023

Event Type  malfunction  

Event Description

It was reported that sometime post a dialysis catheter placement, after using the antiseptic, the colour of two lumens of the catheter allegedly got changed to white and the lumens allegedly got deformed.Reportedly, the catheter was replaced.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the sample was not returned for evaluation.One photo was provided for review.The photo review shows the extension leg of the catheter is noted to be deformed, have stretch, opacification and discoloration.Therefore, the investigation is confirmed for the reported deformation issue.The investigation is also confirmed for the identified discoloration, opacification and stretched issues.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.The instructions for use was reviewed and states that: 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.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 solutions(s).H11: section a through f ¿ the information provided 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.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the sample was not returned for evaluation.One photo was provided for review.The photo review shows deformation, opacification, stretch, protrusion and discoloration on the extension leg of the implanted hemostar catheter.Therefore, the investigation is confirmed for the reported deformation, opacification and discoloration issues.The investigation is also confirmed for the identified stretched and protrusion issues.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.The instructions for use was reviewed and states that: 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.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 solutions(s).H10: g3, h6 (device, result).H11: section a through f ¿ the information provided 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 sometime post a dialysis catheter placement, after using the antiseptic, the colour of two lumens of the catheter allegedly got changed to white and the lumens allegedly got deformed.Reportedly, the catheter was replaced.There was no reported patient injury.

• Brand Name: HEMOSTAR
• Type of Device: DIALYSIS CATHETER
• 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: 18704487
• MDR Text Key: 336539779
• Report Number: 3006260740-2024-00512
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00801741013409
• UDI-Public: (01)00801741013409
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: K051748
• 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

• Date FDA Received: 02/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5833730
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2024
• 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
• Patient Age: 57 YR
• Patient Sex: Male