MAUDE Adverse Event Report: BARD ACCESS SYSTEMS ACCUCATH, 18GX1.25 BASIC; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number AC0181250

Device Problems Detachment Of Device Component (1104); Failure to Advance (2524)

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, frequency 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 that the guidewire wouldn¿t advance with a subsequent inability to safety the accucath needle was inconclusive due to the sample condition.Two photographs were provided for investigation.The first photo showed the needle extending from the accucath handle.The safety mechanism button was visible in the photo.The proximal end of the handle was not captured in the photo.The guidewire was not extending from the distal tip of the needle.Due to the poor image quality, it could not be discerned if the curled tip of the guidewire was positioned at the distal tip of the needle.The 2nd photo showed the needle cover with a label for product code ac0181250 and lot # recp2386.It was reported that the guidewire functioned prior to insertion; however, after insertion, it was reported that the guidewire would not advance.It is possible that the guidewire met resistance while in the patient or became lodged within the needle.It was reported that the needle tip wouldn¿t pierce the vessel easily, which could be associated with the non-functioning guidewire.If the guidewire is not fully advanced when attempting to activate the safety mechanism, the safety mechanism may damage the guidewire, which can prevent the needle from fully retracting within the handle.A review of the manufacturing records showed no evidence that the reported event was caused by the mfg.Process.Since it was reported that the guidewire functioned prior to insertion, the device may have been damaged during use; however, based on the sample condition, the cause of the reported event was inconclusive.A lot history review (lhr) of recp2386 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported the that during placement the rn stuck the patient and couldn¿t see her needle tip after looking for a while.It was stated the rn found a shadow of the needle tip and it wouldn¿t pierce the vessel easily and she felt like it popped in.The rn tried to advance the wire but it wouldn¿t go (it worked prior to insertion).It was reported the accucath wouldn¿t safety and was pulled it out.It was noted that the needle was turned sideways and it would not safety and the wire would not advance.

• Brand Name: ACCUCATH, 18GX1.25 BASIC
• 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: shelly gilbert ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225640
• MDR Report Key: 7602585
• MDR Text Key: 111849921
• Report Number: 3006260740-2018-01377
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741110900
• UDI-Public: (01)00801741110900
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: AC0181250
• Device Catalogue Number: AC0181250
• Device Lot Number: RECP2386
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 05/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2018
• 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