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

Model Number N/A

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.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 that with the insertion of the accucath this morning in the ed, the guidewire became stuck, unable to retract and required a physician to go in and remove.

Event Description

It was reported that with the insertion of the accucath this morning in the ed, the guidewire became stuck, unable to retract and required a physician to go in and remove.

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 accucath insertion difficulty was confirmed; however, the root cause was not identified.The product returned for evaluation was one photograph depicting a 20ga accucath peripheral iv catheter assembly.Usage residues were observed throughout the sample.The guidewire extended from the catheter tip and appeared to be intact.The wire exhibited curved spe memory.The catheter was kinked and bunched at several points along the shaft.The usage residues and deformation of the wire and the catheter suggested that difficulty was experienced during attempted device insertion; however, inspection of the submitted photograph was insufficient to identify the cause.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.Potential contributing factors include attempted advancement into tissue and attempted insertion at a steep angle.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

• Brand Name: 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
• MDR Report Key: 9513412
• MDR Text Key: 174526569
• Report Number: 3006260740-2019-04000
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 01/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 12/13/2019
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/06/2019
• Initial Date FDA Received: 12/23/2019
• Supplement Dates Manufacturer Received: 12/20/2019
• Supplement Dates FDA Received: 01/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention