MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD ACCUCATH MIDLINE CATHETER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problems Break (1069); Retraction Problem (1536); Physical Resistance/Sticking (4012)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

It was reported by bd tm that during training, "we went to place an accucath in the patient¿s cephalic vein in the ed.It was shallow (.25-.5cm deep).It was only the rn's 4th stick, and she had not done one that shallow yet.She had some trouble getting in the vessel, which i think irritated the vein, along with the tourniquet being on for a longer period of time.I spent about 10 minutes trying to coach her through it.Once she finally cannulated it and got flash, the guidewire went smoothly.When she went to thread the catheter, i suspected that there might have been a little resistance.When i asked her if she felt some resistance, she said that she did not think so.When it came time to safety out the device, the device tried to pull the needle and wire out, but we met resistance and were unable to pull it out, which i attributed to a vessel spasm clamping down on it.I told the rn to pop the tourniquet and let the patient¿s arm relax.I then requested that she grab a warm compress.In either the process of initially trying to get the device out or maybe her resistance when threading, i am not sure which, the catheter twisted on the need (think like a wrung, wet towel).Since we had threaded it, the catheter hub was no longer nice and tight on the needle.I think this twisted motion helped the catheter break a little near the hub.Once she got the warm compress, we were able to remove the device.The patient did not complain of pain or discomfort the entire time and he even requested us to ¿try again.¿ next, the rn tried to put a ¿regular¿ 20g piv in this man with a paplation stick.However, it blew immediately.She then tried again on the other arm with the regular 20g piv and was able to gain access and pull his lab work.".

• Brand Name: BARD ACCUCATH MIDLINE CATHETER
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• 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: kayla olsen ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225010
• MDR Report Key: 8760470
• MDR Text Key: 150263400
• Report Number: 3006260740-2019-01868
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 06/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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