MAUDE Adverse Event Report: BARD ACCESS SYSTEMS ACCUCATH INTRAVASCULAR CATHETER; INTRAVASCULAR CATHETER LESS THAN 30 DAYS

Model Number N/A

Device Problem Kinked (1339)

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 complaint of a kink in the accucath catheter is confirmed, but the cause cannot be determined.The sample returned was one photograph, reportedly of an accucath catheter.Visual observation of the returned photograph found that the device did appear to be an accucath catheter, with transparent dressing.The catheter hub and much of the catheter was within the borders of the dressing.The device was not attached to a patient.The catheter hub and distal end of the catheter appeared to manifest red use residues.The catheter was attached to an unidentified clear plastic luer adaptor.The catheter was kinked at the distal end of the purple strain relief.No statlock was found in the photograph, and neither the physical catheter sample nor the statlock in question can be examined for determination of root cause.Possible contributing factors include excessively steep insertion angle and mechanical stress during placement or while used.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 to the bard territory manager by the facility that the accucaths are kinking when used with the designated statlock.The facility has reportedly since moved to securis and this has solved the reported problem.

• Brand Name: ACCUCATH INTRAVASCULAR CATHETER
• Type of Device: INTRAVASCULAR CATHETER 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: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 6541769
• MDR Text Key: 74490578
• Report Number: 3006260740-2017-00548
• 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: Nurse
• Type of Report: Initial
• Report Date: 05/03/2017

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: N/A
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/11/2017
• Initial Date FDA Received: 05/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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