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

Model Number	AC0201250
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Type of Reportable Event	Serious Injury
Additional 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 to the manufacturer for evaluation, as the device is being retained by the reporting facility.A lot history review (lhr) of recr1226 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
Clinical specialist states she was assisting a nurse insert an accu cath.She states the nurse was unable to place the catheter due to resistance.Upon removing the catheter they noted the curl on the tip of the guidewire was missing.(b)(6) discussed placement technique.The facility called and stated that the fragment of the wire broken off and remained in the patient.The patient had to have the fragment removed by a surgeon in the ir department.
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation, as the device is being retained by the reporting facility.A lot history review (lhr) of recr1226 showed no other similar product complaint(s) from this lot number.(b)(4).
Event or Problem Description
Clinical specialist states she was assisting a nurse insert an accucath.She states the nurse was unable to place the catheter due to resistance.Upon removing the catheter they noted the curl on the tip of the guidewire was missing.Ms&s discussed placement technique.The facility called and stated that the fragment of the wire broken off and remained in the patient.The patient had to have the fragment removed by a surgeon in the ir department.09/11/2018 per medwatch: attempted to insert a 20g x 1.25 inch accucath into left lower cephalic vein and was unsuccessful.After activating the safety feature, the coil tip guidewire was examined.Coil of the guidewire was not present.Inspected the insertion site and a bump was noted at the site.It appeared to be the coil of the tip.Surgical was consulted and removed the coiled tip from the left lower forearm.

• Brand Name: ACCUCATH, INTRAVASCULAR CATHETER 20 GX1.25
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7813748
• Report Number: 3006260740-2018-02222
• Device Sequence Number: 182565
• Product Code: FOZ
• UDI-Device Identifier: 00801741110917
• UDI-Public: (01)00801741110917
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K153298
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2018
• Report Date (Section F): 09/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: AC0201250
• Device Catalogue Number: AC0201250
• Device Lot Number: RECR1226
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Date Report to Manufacturer: 09/10/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/10/2018
• Initial Report FDA Received Date: 08/24/2018
• Supplement Report FDA Received Date: 09/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention