MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HEMOSTAR LONG-TERM HEMODIALYSIS CATHETER 14.5F STANDARD KIT (STRAIGHT) (23CM); CATHETER, HEMODIALYSIS, IMPLANTED

Model Number 5833730

Device Problems Bent (1059); Kinked (1339)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/20/2017

Event Type  malfunction  

Manufacturer Narrative

The information provided by bard 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 bard.The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of rebv0845 showed no other similar product complaint(s) from this lot number.

Event Description

Reported bent guidewire.There is no reported patient injury.On 03/08/2018-sample evaluation found kinked guidewire.

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a bent guidewire is confirmed and was determined to be use related.One 0.035 in.J-tip guidewire, one 8 fr dilator, and one 12 fr dilator were returned for evaluation.An initial visual observation showed the guidewire was kinked and bent approximately 3 cm and 5 cm from the beginning of the curve of the j-tip, respectively.Blood residue was observed throughout the guidewire and the 12 fr dilator.The tip of 12 fr dilator was observed to be slightly damaged.The core wire of the guidewire was observed to be intact during tactile evaluation.A microscopic observation revealed the coils of the outer wire of the guidewire were misaligned in two locations.The distal tip of the 12 fr dilator was observed to be damaged and one point appeared to have been pulled inward slightly, likely by the guidewire.The location of the damage observed on the guidewire and the nature of the damage observed on the distal tip of the 12 fr dilator as well as the amount of use residue observed on the returned samples suggest the guidewire was most-likely damaged during use.The product ifu states: ¿do not pull back standard guidewire over needle bevel as this could sever the end of the guidewire.The introducer needle must be removed first.¿ a lot history review (lhr) of rebv0845 showed no other similar product complaint(s) from this lot number.

Event Description

Reported bent guidewire.There is no reported patient injury.03/08/2018-sample evaluation found kinked guidewire.

• Brand Name: HEMOSTAR LONG-TERM HEMODIALYSIS CATHETER 14.5F STANDARD KIT (STRAIGHT) (23CM)
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: teresa johnson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225435
• MDR Report Key: 7383313
• MDR Text Key: 104076322
• Report Number: 3006260740-2018-00542
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00801741013409
• UDI-Public: (01)00801741013409
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K051748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5833730
• Device Catalogue Number: 5833730
• Device Lot Number: REBV0845
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 04/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2017
• 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