MAUDE Adverse Event Report: BARD ACCESS SYSTEMS ACCUCATH INTRAVASCULAR CATHETER 20 GX2.25; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number AC0202250

Device Problems Material Frayed (1262); Difficult to Insert (1316); Difficult to Remove (1528); Sticking (1597); Physical Resistance (2578); Device Or Device Fragments Location Unknown (2590)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/19/2018

Event Type  Injury  

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 device has not been returned, at this time, to the manufacturer for evaluation.A lot history review (lhr) of reby2216 showed no other similar product complaint(s) from this lot number.[mw5076570.Pdf].Device has not yet been returned for evaluation.

Event Description

It was reported that an accucath insertion using sonosite to guide was attempted after an unsuccessful attempt to first place a peripheral line.Vessel was reportedly very difficult to access, and a "pop" was felt during access of the vessel.Staff was able to see the end of the iv was placed in the middle of the vessel, and then advanced the guide wire without issue.When advancing the catheter over the guide wire the catheter was only able to advance halfway.Nurse attempted to de-access, but was unable to remove the catheter.When attempting to remove the stuck catheter, the catheter would pull on the guide wire, which was speculated to have been lodged in the vessel wall.A 'red cap' was placed on the line, and secured.A separate accucath line was placed in the other arm without issue.Patient was then re-positioned, and the catheter was removed from the arm with some resistance.No swelling, bruising, or pain was noted.The catheter that was removed had a tear with frayed edges in the middle.The wire was confirmed to be located in the vessel, and patient was taken to the or to remove the accucath and wire that remained in the arm.

• Brand Name: ACCUCATH INTRAVASCULAR CATHETER 20 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: 7555362
• MDR Text Key: 109616824
• Report Number: 3006260740-2018-01149
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741110948
• UDI-Public: (01)00801741110948
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/17/2018,05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Model Number: AC0202250
• Device Catalogue Number: AC0202250
• Device Lot Number: REBY2216
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/17/2018
• Distributor Facility Aware Date: 03/19/2018
• Event Location: Hospital
• Date Report to Manufacturer: 05/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2017
• 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
• Patient Outcome(s): Required Intervention