MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 ACCUCATH ACE INTERMEDIATE KIT CATHETER (20G) CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problem Material Deformation (2976)

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

Event Date 02/11/2021

Event Type  malfunction  

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling. Based on a review of this information, the following was concluded: the complaint of a damaged catheter was confirmed, but the exact cause could not be determined. One accucath ace was returned for investigation. The deployment system was received with the safety mechanism activated. The needle was fully retracted in the handle. The catheter was received over the section of guidewire that extended from the handle. The entire length of the catheter was crumpled, deformed, and curled over the guidewire. A microscopic examination of the catheter revealed the coiled tip of the guidewire was extending from the tip of the catheter. The catheter was removed from the guidewire. After removal, the catheter was stretched out and no portion of the tubing appeared to be missing. The coil at the distal end of the guidewire was deformed. The valve actuator was not engaged through the valve. Since the catheter was damaged and received over the wire, the complaint was confirmed. What caused the catheter to crumple could not be determined from the sample analysis and it is unknown if the damage occurred prior to or after the activation of the safety mechanism. A lot history review (lhr) of reey2691 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported "nurse and picc specialist were placing an accucath in a patient yesterday that needed a peripheral iv. I'm not sure exactly what happened but i believe there was a malfunction with the accucath. Nurse placed the accucath with no issue but when he pressed the button to retract the needle and remove the guide wire, it seemed to be caught somewhere on the catheter. The wire could not be removed from the catheter at all. It was a little difficult to remove the catheter also after we decided to terminate the iv. When we took it out, i inspected it and it looks like the curled part on the end of the guide wire seemed to be wrapped around the catheter tip. " 06/08/2021: the returned device was found kinked.

• Brand Name: ACCUCATH ACE INTERMEDIATE KIT CATHETER (20G)
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 12103654
• MDR Text Key: 259640471
• Report Number: 3006260740-2021-02550
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162894
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: AC1201252
• Device Lot Number: REEY2691
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2021
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 07/01/2021 Patient Sequence Number: 1