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

Model Number 5833730

Device Problems Fluid/Blood Leak (1250); Air/Gas in Device (4062)

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

Event Date 01/05/2023

Event Type  malfunction  

Manufacturer Narrative

H10: 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, a video was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 03/2024).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 during a dialysis catheter placement procedure, air was allegedly drawn into the introducer needle.It was further reported that when the tip of the introducer needle was blocked, saline allegedly leaked out of the handle of the introducer needle when injecting the saline with the syringe.The procedure was completed using another needle.There was no reported patient injury.

Event Description

It was reported that during a dialysis catheter placement procedure, air was allegedly drawn into the introducer needle.It was further reported that when the tip of the introducer needle was blocked, saline allegedly leaked out of the handle of the introducer needle when injecting the saline with the syringe.The procedure was completed using another needle.There was no reported patient injury.

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 sample was not returned for evaluation.One electronic video was provided for review.The video shows a clinician trying to infuse water through a introducer needle.Further upon infusion, leak was noted near the hub of the introducer needle.Therefore, the investigation is confirmed for the reported fluid leak.However, the investigation is inconclusive for the reported air/gas in device as the exact circumstances at the time of the reported event cannot be verified from the provided video.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.H10: d4 (expiration date: 03/2024), g3 h11: h6 (method, 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.

• 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: 17149839
• MDR Text Key: 317848281
• Report Number: 3006260740-2023-02492
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00801741013409
• UDI-Public: (01)00801741013409
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 08/18/2023

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
• Device Operator: Health Professional
• Device Model Number: 5833730
• Device Catalogue Number: 5833730
• Device Lot Number: REGT3502
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/22/2023
• Initial Date FDA Received: 06/19/2023
• Supplement Dates Manufacturer Received: 08/18/2023
• Supplement Dates FDA Received: 08/22/2023
• 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