MAUDE Adverse Event Report: BARD ACCESS SYSTEMS ACCUCATH INTRAVASCULAR CATHETER 20 GX2.25

Model Number AC0202250

Device Problem Hole In Material (1293)

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

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 rebu1351 showed no other similar product complaint(s) from this lot number.

Event Description

Facility reported to the sales rep that there was a puncture in the catheter of the accucath.No harm to the patient.No other information was provided.

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 puncture in the accucath catheter was confirmed, and the damage appeared to be use related.One 20g x 2.25¿ accucath catheter was returned for investigation.Evidence of use was observed on the returned sample.The catheter was received separate from the deployment system.The safety mechanism had been engaged and the needle was fully retracted within the handle.Blood residue was observed within the handle.The guidewire was kinked approximately 1.6cm from the distal tip.Both the valve and the flow actuator were received over the guidewire.No valve and flow actuator were located within the pink accucath hub.The dimensions of the valve and flow actuator were within specification.A functional test revealed a spraying leak 3.4cm from the distal tip of the catheter.A microscopic examination of the leak site revealed a symmetrical hole.The inner lumen to external catheter surface trajectory was from the proximal to distal end of the catheter.The characteristics of the hole are consistent with a needle tip puncture.The product ifu states, ¿once the catheter has been advanced, do not re-insert the needle back into the catheter or pull the catheter back onto the needle.If the catheter needs to be repositioned, either do so without the aid of the needle, or remove both the catheter and the needle as a unit to prevent the needle from damaging or shearing the catheter.¿ the complications and manipulation of the device during use appeared to have both damaged the catheter and guidewire and caused the valve and flow actuator to separate from the needle hub.Due to the evidence of use and since the components were within specification, it appears that the device was damaged during use.

Event Description

Facility reported to the sales rep that there was a puncture in the catheter of the accucath.No harm to the patient.No other information was provided.

• Brand Name: ACCUCATH INTRAVASCULAR CATHETER 20 GX2.25
• Type of Device: INTRAVASCULAR CATHETER
• 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: shauna nielson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225536
• MDR Report Key: 6895210
• MDR Text Key: 87609867
• Report Number: 3006260740-2017-01708
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741110948
• UDI-Public: (01)00801741110948
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153298
• 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: 11/16/2017

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 Model Number: AC0202250
• Device Catalogue Number: AC0202250
• Device Lot Number: REBU1351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 09/18/2017
• Initial Date FDA Received: 09/26/2017
• Supplement Dates Manufacturer Received: 10/18/2017
• Supplement Dates FDA Received: 11/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2017
• 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