MAUDE Adverse Event Report: BARD ACCESS SYSTEMS ACCUCATH INTRAVASCULAR CATHETER 20 GX2.25; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problems Difficult to Flush (1251); Material Twisted/Bent (2981)

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

Event Date 05/15/2019

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of redn3201 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the accucath would not flush, "it also would not go back in straight shape of catheter, it stayed bend".On (b)(6) 2019: no patient harm was reported, but had to remove iv catheter.

Event Description

It was reported that the accucath would not flush, "it also would not go back in straight shape of catheter, it stayed bend." 5/17/19: no patient harm was reported, but had to remove iv catheter.

Manufacturer Narrative

H11:section a through f - the information provided by bd 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 bd.The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of inability to flush the sample was unconfirmed because the problem could not be reproduced.The product returned for evaluation was one 20ga x 2.25¿ accucath peripheral iv catheter.Usage residues were observed throughout the sample.The catheter exhibited slight curved shape memory.An attempt to infuse water through the sample using a 12ml syringe revealed the sample to be patent to infusion and aspiration with no observed leaks.The effort required to flush the sample was comparable to that required to flush a similar non-complainant device.Microscopic inspection of the sample did not reveal any evidence of device occlusion or kinking.No deficiencies were discovered during evaluation of the returned sample.Consequently this complaint is unconfirmed at this time.

• Brand Name: ACCUCATH INTRAVASCULAR CATHETER 20 GX2.25
• 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
• MDR Report Key: 8675915
• MDR Text Key: 147306773
• Report Number: 3006260740-2019-01571
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741110948
• UDI-Public: (01)00801741110948
• Combination Product (y/n): N
• PMA/PMN Number: K153298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2019
• 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: AC0202250
• Device Lot Number: REDN3201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2019
• Event Location: Hospital
• Date Manufacturer Received: 06/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1