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

Model Number 5833690

Device Problems Break (1069); Fluid/Blood Leak (1250); Fracture (1260); Difficult to Insert (1316); Difficult to Remove (1528); Suction Problem (2170); Failure to Advance (2524); Physical Resistance/Sticking (4012)

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

Event Date 12/12/2022

Event Type  malfunction  

Event Description

It was reported that during preparation of a dialysis catheter placement procedure, the introducer needle was allegedly found to be not vaccumed after opening the puncture kit.It was further reported that during injection by the syringe, external leakage occurred on needle tip and the needle was allegedly broken.Reportedly, the guide wire got stuck when being inserted and unable to be advanced or retracted.There was no patient contact.

Manufacturer Narrative

H10: 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, a photo was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 07/2023).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: device pending return.

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, one electronic photo was provided for review.The photo shows the partial view of the tip of the introducer needle and the j-tip of the guidewire was noted to be stuck inside the introducer needle.However, the investigation is inconclusive for the reported needle fracture, leak, physical resistance, suction problem, difficult to remove and failure to advance issues as there was no objective evidence provided and the reported issues cannot be confirmed from the provided photo.The definitive root cause could not be determined based upon available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiry date: 07/2023), g3, h6 (device, method).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.

Event Description

It was reported that during preparation of a dialysis catheter placement procedure in jugular vein, the introducer needle was allegedly found to be not vacuumed after opening the puncture kit.It was further reported that during injection by the syringe, external leakage occurred on needle tip and the needle was allegedly broken.Reportedly, the guide wire got stuck when being inserted and unable to be advanced or retracted.There was no patient contact.

• 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: 17134330
• MDR Text Key: 317251080
• Report Number: 3006260740-2023-02448
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00801741013386
• UDI-Public: (01)00801741013386
• 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: 09/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5833690
• Device Catalogue Number: 5833690
• Device Lot Number: REFX0654
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2021
• 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