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

Model Number	5735190
Medical Device Problem Codes	Disconnection (1171); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Insufficient Information (4580)
Date of Event	07/06/2021
Type of Reportable Event	Death
Additional 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 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: 05/2018).
Event or Problem Description
It was reported that venous hub of catheter noted to be disconnected from the lumen of the catheter.Hemaclip to bloodiness remained in place.Blood loss from disconnection noted.Reportedly patient expired.
Additional Manufacturer Narrative
H10: manufacturing review: a complaint history review was performed.This is the first complaint reported for this product and lot.Therefore, a device history record review is not required.Investigation summary: the sample was not returned to the manufacturer for evaluation.Therefore, investigation is inconclusive for the reported disconnection of the venous catheter hub from the extension leg lumen issue.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 following statements: "in the rare event of a leak, the catheter should be clamped immediately.Necessary remedial action must be taken prior to resuming dialysis or infusion procedure." "repeated over tightening of blood lines, syringes and caps will reduce connector life and could lead to potential connector failure.In case of damage, clamp the catheter between the patient and the damaged area with a smooth-edged, atraumatic clamp." h10: b5, d4 (expiry date: 05/2018), g3, h6 (patient).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.
Event or Problem Description
It was reported that approximately five years post catheter placement, venous hub of catheter was allegedly noted to be disconnected from the lumen of the catheter.It was further reported that the bloodline connector remained in place.Blood loss from disconnection noted.Reportedly patient expired.
Additional 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 disconnection of the venous catheter hub from the extension leg lumen as no objective evidence was provided for review.A definitive root cause for the reported hub disconnection could not be determined based upon the provided 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 following statements: "in the rare event of a leak, the catheter should be clamped immediately.Necessary remedial action must be taken prior to resuming dialysis or infusion procedure." "repeated over tightening of blood lines, syringes and caps will reduce connector life and could lead to potential connector failure.In case of damage, clamp the catheter between the patient and the damaged area with a smooth-edged, atraumatic clamp." "1.To check catheter patency attach a 10 ml syringe with sterile normal saline to each lumen of the catheter.Release the catheter clamp and aspirate blood through each lumen.Once flow is satisfactory, flush both lumens with heparinized saline in amounts equal to the priming volume of each lumen.Clamp each lumen immediately.Warning: failure to clamp can lead to air embolism." "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)." "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." "close all clamps only in the center of the extension legs.Extensions may develop cuts or tears if subjected to excessive pulling or contact with rough edges.Repeated clamping near or on the luer lock connectors may cause tubing fatigue and possible disconnection." h10: d4 (expiry date: 05/2018), g3.H11: g1, h6 (device).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.
Event or Problem Description
It was reported that approximately five years post catheter placement, venous hub of catheter was allegedly noted to be disconnected from the lumen of the catheter.It was further reported that the bloodline connector remained in place.Blood loss from disconnection noted.Reportedly patient expired.

• 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: 12286451
• Report Number: 3006260740-2021-03187
• Device Sequence Number: 19628455
• Product Code: MSD
• UDI-Device Identifier: 00801741013188
• UDI-Public: (01)00801741013188
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K030020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 5735190
• Device Catalogue Number: 5735190
• Device Lot Number: REAT1500
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/14/2021
• Supplement Date Received by Manufacturer: 12/09/2021; 07/15/2022
• Initial Report FDA Received Date: 08/06/2021
• Supplement Report FDA Received Date: 12/10/2021; 07/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Other; Death
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White