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

Catalog Number	5733690
Medical Device Problem Codes	Material Discolored (1170); Material Opacification (1426); Stretched (1601); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records will be performed.The device has not been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiration date: 01/2025).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.
Event or Problem Description
It was reported that six months and one day post a dialysis catheter placement, the catheter hubs were allegedly getting weaker, causing ballooning while flushing and also catheter hub color was allegedly changed to pale yellow.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the physical device was not returned for evaluation.Two electronic photos were provided for review.The photo shows catheter discoloration on both luer.Catheter bulging was noted to the blue luer near the clamp.Therefore, the investigation is confirmed for the reported material discoloration, material stretch and protrusion.A definitive root cause could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiration date: 01/2025), g3, h6 (method).H11: h6 (result, conclusion).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 or Problem Description
It was reported that six months and one day post a dialysis catheter placement, the catheter hubs were allegedly getting weaker, causing ballooning while flushing.It was further reported that the color of the catheter hub was allegedly changed to pale yellow.There was no reported patient injury.
Event or Problem Description
It was reported that six months and one day post a dialysis catheter placement, the catheter hubs were allegedly getting weaker, causing ballooning while flushing.It was further reported that the color of the catheter hub was allegedly changed to pale yellow.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: although the physical device was not returned, two electronic photos were provided for review.The first photo shows catheter discoloration on both luer.Catheter bulging was noted to the blue luer near the clamp.Both extension legs were opaque near the bifurcation area.The second photo shows the xepi skin prep antiseptic liquid bottle that was not included in the prohibited chemicals to be used on the catheter as per ifu, but the fluids used are supposed to be left to dry before the device is dressed again.Therefore, the investigation is confirmed for the reported material discoloration, material stretch, protrusion issues and identified material opacification.A definitive root cause could not be determined based upon the provided information.Labeling review: adequate 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.Ifu reviewed: baw0727959, rev.0 ifu warns: *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.

• Brand Name: HEMOSPLIT CATHETER
• Common Device Name: 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: 18899908
• Report Number: 3006260740-2024-01073
• Device Sequence Number: 15413833
• Product Code: MSD
• UDI-Device Identifier: 00801741013096
• UDI-Public: (01)00801741013096
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K030020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/23/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2025
• Device Catalogue Number: 5733690
• Device Lot Number: REHQ4676
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/16/2024
• Supplement Date Received by Manufacturer: 04/22/2024; 08/23/2024
• Initial Report FDA Received Date: 03/13/2024
• Supplement Report FDA Received Date: 04/25/2024; 09/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/09/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown