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

Model Number	5903190
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2021
Type of Reportable Event	Malfunction
Additional 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 and a photo was provided for review.The investigation of the reported event is currently underway.(expiry date: 09/2021).Device pending return.
Event or Problem Description
It was reported that one year and three months post dialysis catheter placement, the catheter allegedly had a break.The procedure was completed using another device.There was no reported patient injury.
Event or Problem Description
It was reported that one year and three months post dialysis catheter placement, the catheter allegedly had a break.The procedure was completed using another device.There was no reported patient injury.
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 sample was not returned for evaluation, one electronic photo was provided for review.The investigation is confirmed for the reported catheter break issue, as the extension leg of the device appeared to be cut on the provided photo.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 (expiry date: 09/2021), h11: h6 (result, conclusion), 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.H3 other text : device not returned.
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: one arterial extension leg segment was returned for evaluation and one electronic photo was provided for review.Gross visual, microscopic visual and functional evaluations were performed in the returned device.During visual evaluation, a complete diagonal break was noted to the extension leg approximately 4.3cm from the strain relief.Further, the surface of the complete diagonal break was has striations in one region and granular in another and the edges were sharp and smooth.The investigation is inconclusive for the reported catheter fracture issue as the exact circumstances at the time of the reported event are unknown and further, striations were noted on one region of the break surface.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 (expiry date: 09/2021).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.H3 other text : see h10.
Event or Problem Description
It was reported that one year and three months post dialysis catheter placement, the catheter allegedly had a break.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: EQUISTREAM SPLIT TIP
• 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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 13073825
• Report Number: 3006260740-2021-05404
• Device Sequence Number: 14734386
• Product Code: MSD
• UDI-Device Identifier: 00801741013690
• UDI-Public: (01)00801741013690
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K090101
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/11/2022

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
• Operator of Device: Health Professional
• Device Model Number: 5903190
• Device Catalogue Number: 5903190
• Device Lot Number: REDZ3275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/25/2021
• Supplement Date Received by Manufacturer: 12/27/2021; 01/11/2022
• Initial Report FDA Received Date: 12/23/2021
• Supplement Report FDA Received Date: 12/29/2021; 01/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Female