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

Catalog Number 6903190

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

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

Event Date 02/13/2023

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 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.Device not returned.

Event Description

It was reported that during a dialysis catheter placement procedure, the catheter allegedly had a laceration in one of the catheter pathways and air was allegedly noticed in the catheter.It was further reported that blood had allegedly came out at the site of the catheter that was found lacerated.There was no reported patient injury.

Event Description

It was reported that during a dialysis catheter placement procedure, the catheter allegedly had a laceration in one of the catheter pathways and air was allegedly noticed in the catheter.It was further reported that blood had allegedly came out at the site of the catheter that was found lacerated.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 for evaluation.Four electronic photos were provided for review.The photos show one equistream split tip catheter implanted in a patient body.Therefore, the investigation is inconclusive for the reported material puncture and leak issue as there was no objective evidence obtained from the provided photos.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: 12/2023).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: 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: 16527230
• MDR Text Key: 311255613
• Report Number: 3006260740-2023-00774
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 05/22/2023

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 Catalogue Number: 6903190
• Device Lot Number: REGQ1178
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2023
• Initial Date FDA Received: 03/12/2023
• Supplement Dates Manufacturer Received: 05/22/2023
• Supplement Dates FDA Received: 05/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2022
• 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