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

Catalog Number 6903270

Device Problems Obstruction of Flow (2423); Deformation Due to Compressive Stress (2889)

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

Event Date 05/02/2022

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.However, photos were provided for review.The investigation of the reported event is currently underway.(expiration date: 03/2023).

Event Description

It was reported that approximately three months and twenty one days post dialysis catheter placement procedure, the catheter allegedly had deformation in both ways that impeded the flow.There was no reported patient injury.

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 sample was not returned to the manufacturer for evaluation.However, two electronic photos were provided for review.The photos shows the partial view of the extension legs of one equistream split tip catheter.Kink was noted on both the extension legs near the clamping area.Blood like fluid was noted inside the arterial extension leg in the second photo.However, the extension legs appeared kinked at the same point.Therefore, the investigation is confirmed for the reported deformation issue.However, the investigation is inconclusive for the reported obstruction issue as the exact circumstances at the time of the reported event cannot be verified.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.H10: d4 (expiry date: 03/2023), g3.H11: e1, e3, h6 (method, result, conclusion).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.H3 other text : device not returned.

Event Description

It was reported that approximately three months and twenty one days post port placement procedure, the port allegedly had deformation in both ways that impeded the flow.Reportedly, the device was removed from the patient and the procedure was completed using another device.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: 14540055
• MDR Text Key: 292958786
• Report Number: 3006260740-2022-02017
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00801741121661
• UDI-Public: (01)00801741121661
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6903270
• Device Lot Number: REFR3275
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2021
• 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