MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 20GA, ACCUCATH IV CATHETER, 1.25", BASIC; INTRAVASCULAR CATHETER

Catalog Number	AC0201250
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/16/2017
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 manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
Sales rep reported that while at the facility during training on (b)(6) 2017, the healthcare professional placed the device and the procedure went well.The facility contacted the sales rep on (b)(6) 2017, and stated that the catheter broke off at the hub and migrated.Surgery will be required for removal.No patient harm was reported.On 2/17/2017 - additional information received from bard clinical specialist.She reported that she was present at time of placement.The catheter was placed without any complications and was present in the patient's vein.Device was placed at 10:00 am on wednesday, (b)(6) 2017.The patient was transferred from the emergency room to the inpatient floor.When the night nurse checked the patient's dressing at 7:00 pm, the nurse stated the patient's dressing was wet.The dressing was partially lifted and the nurse noted some leaking and checked the extensions.A new iv was placed.Nurse then reported the dressing was completely soaked through.She removed the dressing and noted the catheter was missing.Nurse stated the catheter was no where to be seen on the outside of the patient's body.An x-ray and ultrasound was done on the patient's arm and chest to confirm catheter migration.The facility has reported that since the device is radiopaque and is not visible on the x-ray and/or ultrasound there is not further follow up with the patient.The patient is still in the hospital at this time.
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.
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 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 of a damaged accucath catheter was confirmed, but the exact cause is unknown.One photograph was returned for investigation.The pink and purple hub of what appears to be an accucath device was on top of what appears to be a white absorbent towel.A statlock securement device and extension set were attached to the pink hub.The image is out of focus, but no part of the catheter is visible in the photograph.It cannot be determined if the catheter broke near the distal end of the purple strain relief sleeve.At this time, based on the evidence provided with the returned photograph, it is unknown what caused the reported catheter break.

• Brand Name: 20GA, ACCUCATH IV CATHETER, 1.25", BASIC
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6388844
• Report Number: 3006260740-2017-00208
• Device Sequence Number: 550312
• Product Code: FOZ
• UDI-Device Identifier: 00801741110917
• UDI-Public: (01)00801741110917
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K153298
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/20/2017

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: AC0201250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2017
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/17/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/08/2017
• Supplement Report FDA Received Date: 03/16/2017; 03/20/2017
• 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: Hospitalization