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

Catalog Number 6903190

Device Problems Fracture (1260); Stretched (1601); Failure to Advance (2524); Deformation Due to Compressive Stress (2889); Material Protrusion/Extrusion (2979)

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

Event Date 09/04/2022

Event Type  malfunction  

Manufacturer Narrative

Manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one 19cm equistream d/l catheter, two end caps, one 16.0fr peel-apart sheath, one vessel dilator, one 8fr & 12fr dilator, one introducer needle with a loaded guidewire in a guidewire hoop were returned for evaluation.Gross visual, microscopic visual, dimensional evaluation and functional testing were performed.The investigation is inconclusive for the reported guidewire advancement issue as the exact circumstances at the time of the reported event cannot be verified and the sample evaluation results indicating no difficulty under laboratory conditions are not by themselves sufficient to confirm that this event did not occur under clinical conditions.However, the investigation is confirmed for the reported guidewire damage, identified protrusion, uncoiling and fracture issues as the guidewire appeared to be uncoiling, distal to the introducer needle hub.Distal tip of the guidewire was noted to be bent.Furthermore, a flat core wire was noted to be protruding the uncoiled guidewire area and a complete break was noted on the distal end of the exposed flat core wire.Based on the measurements recorded during sample evaluation and applicable drawings, no measurements recorded could be confirmed to be out of tolerance.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.(expiry date: 03/2023).

Event Description

It was reported that during a dialysis catheter placement procedure, the thread allegedly did not pass through the needle.It was further reported that thread allegedly damaged.There was no reported patient injury.

• Brand Name: EQUISTREAM SPLIT TIP
• 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: 16222925
• MDR Text Key: 308251882
• Report Number: 3006260740-2022-06096
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00801741121647
• UDI-Public: (01)00801741121647
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K090101
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6903190
• Device Lot Number: REFR3273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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: 66 YR