MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 20GA, ACCUCATH IV CATHETER, 2.25", BASIC; INTRAVASCULAR CATHETER

Catalog Number AC0202250

Device Problems Sticking (1597); Device Operates Differently Than Expected (2913)

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

Event Date 02/07/2017

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 difficulty inserting the accucath catheter was confirmed; however, the cause was undetermined.The product returned for evaluation was one 20ga x 2.25¿ accucath peripheral iv catheter assembly.The sample was received assembled.Blood residue was observed throughout the catheter and introducer needle.Blood residue was observed occluding the catheter at the needle flash port.The guidewire was not mobile within the device and the safety mechanism could not be engaged.Blood product occlusion appeared to be preventing guidewire mobility.Greater effort was required to remove the catheter from the needle than that required for a similar non-complainant device.Microscopic inspection catheter revealed slight bulging in the vicinity of the needle flash port.Slight buckling of the catheter was also observed just distal of the luer hub.Inspection of the needle tip revealed a region of increased luster along the inside edge of the bevel.Also received was one photograph depicting the distal end of an accucath assembly.The catheter was removed from the device depicted in the photograph and the guidewire was protruding from the needle flash port.The observed inability of the guidewire to move within the needle and accompanying inability to activate the safety appeared to be the result of occluding blood product occlusion.The photograph depicted the guidewire protruding from the needle flash port and this observation was reinforced by the observed bulging in the complaint catheter.The increased luster on the needle bevel indicated that the guidewire had protruded from the needle bevel at some point, suggesting that the movement of the guidewire to the flash port was caused by device handling; however, it could not be determined precisely how that movement occurred.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.Potential contributing factors include a too-sharp insertion angle and failure to properly access the vessel prior to attempted wire advancement.The product ifu states ¿warning: do not force or retract the guidewire.¿ a lot history review (lhr) of reay0001 showed three other similar product complaint(s) from this lot number.

Event Description

Per sales rep, the facility reported that the patient was accessed with the accucath catheter, vessel was entered, guidewire deployed, and in an attempt to thread catheter, the catheter would not move.It was stated that the wire was retracted back into the housing, needle repositioned, the wire would not fully extend and the catheter would not move.The nurse pulled the catheter and the needle out of the patient.The device showed the wire was coming out of the shaft of the needle and not the bevel.

• Brand Name: 20GA, ACCUCATH IV CATHETER, 2.25", BASIC
• Type of Device: INTRAVASCULAR CATHETER
• 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: teresa johnson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225435
• MDR Report Key: 6375024
• MDR Text Key: 69266611
• Report Number: 3006260740-2017-00185
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741110948
• UDI-Public: (01)00801741110948(17)180228(10)REAY0001
• 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: user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: AC0202250
• Device Lot Number: REAY0001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 02/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2016
• 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