MAUDE Adverse Event Report: BARD ACCESS SYSTEMS ACCUCATH, 18 GX2.25; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number AC0182250

Device Problems Bent (1059); Hole In Material (1293); Retraction Problem (1536)

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 following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a bent needle and failure of the needle to retract into the device housing; however, the root cause was not identified.The product returned for evaluation was one 18ga x 2.25¿ accucath peripheral iv catheter assembly.The sample was received assembled with the catheter overlaying the needle shaft.The needle shaft was bent at the exit site from the needle carrier.The guidewire was not mobile within the needle.The safety button was depressed; however, the needle was only partially withdrawn into the housing.Guidewire mobility and safety mechanism functionality were established by straightening the needle shaft.Inspection of the guidewire revealed the distal end to be broken.The break site was primarily granular and exhibited a region of increased luster.Microscopic inspection of the device revealed that the portion of guidewire was trapped between the catheter and the needle shaft.The failure of the needle to retract into the housing was caused by guidewire immobility, which was a result of the bend in the needle shaft.It appeared that catheter manipulation while the guidewire was immobile caused the observed guidewire damage.The cause of the bend in the needle shaft was not identified.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.A lot history review (lhr) of rebx1920 showed one other similar product complaint(s) from this lot number.

Event Description

It was reported by nurse at the facility that the needle has a hole in it, it is bent and would not retract back into the body for safety.On 4/18/2018 - returned sample has a broken guidewire.

• Brand Name: ACCUCATH, 18 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
• 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: 7498703
• MDR Text Key: 107828667
• Report Number: 3006260740-2018-00923
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741110931
• UDI-Public: (01)00801741110931
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/09/2018

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: AC0182250
• Device Catalogue Number: AC0182250
• Device Lot Number: REBX1920
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2018
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/18/2018
• Initial Date FDA Received: 05/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2017
• 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