MAUDE Adverse Event Report: BARD ACCESS SYSTEMS ACCUCATH, INTRAVASCULAR CATHETER 20 GX1.25; CATHETER,INTRAVASCULAR,THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problem Material Twisted/Bent (2981)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

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 a bent accucath was confirmed; however, the root cause was not identified.The product returned for evaluation was one 20ga x 1.25¿ accucath peripheral iv catheter assembly.No obvious usage residues were observed.The needle shaft exhibited a sharp bend just distal of the needle carrier.Microscopic inspection of the needle tip was unremarkable.Inspection of the bend site did not reveal any surface damage.While a sharp bend in the needle shaft was observed, no evidence was observed that identified the cause of the bend.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.Potential contributing factors include device manipulation prior to or during attempted use.A lot history review (lhr) of redp0679 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that prior to use when opening the package, end-user noticed the catheter bent at hub of catheter.Product was quarantined and not used on patient.

• Brand Name: ACCUCATH, INTRAVASCULAR CATHETER 20 GX1.25
• 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
• 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: 9344744
• MDR Text Key: 167174370
• Report Number: 3006260740-2019-03592
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741110917
• UDI-Public: (01)00801741110917
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2019
• 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: AC0201250
• Device Lot Number: REDP0679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2019
• Event Location: Hospital
• Date Manufacturer Received: 10/30/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2019
• 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