MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BASIC KIT 18G X 10 CM WITH BIOPATCH; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	F318107T
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
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) of recp2041 showed one other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the nurse placed device in upper arm at a bifurcation, deployed wire, then attempted to retract wire and it would not retract.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a damaged wire was confirmed, but the exact cause could not be determined from the provided photographs.The physical sample was not returned for investigation.The first of three photographs showed the powerglide deployment system.It appeared that the safety mechanism was engaged over the needle tip.The catheter wings and catheter appeared to be attached to the safety mechanism.What appeared to be a wire was visible in the photograph parallel to the deployment system.It appeared that the wire was unraveled.It could not be determined if the material that resembled a wire was attached to the deployment system.The 2nd and 3rd photographs show the product labeling with part number and lot number identified.This type of damage can occur if the wire is damaged against the needle bevel; however, since the physical sample was not returned for investigation, the cause of the complaint was undetermined.A lot history review (lhr) of recp2041 showed one other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the nurse placed device in upper arm at a bifurcation, deployed wire, then attempted to retract wire and it would not retract.

• Brand Name: BASIC KIT 18G X 10 CM WITH BIOPATCH
• 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: 7919063
• Report Number: 3006260740-2018-02646
• Device Sequence Number: 13824112
• Product Code: FOZ
• UDI-Device Identifier: 00801741140518
• UDI-Public: (01)00801741140518
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K162377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: F318107T
• Device Catalogue Number: F318107T
• Device Lot Number: RECP2041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 08/09/2018
• Supplement Date Received by Manufacturer: 10/25/2018
• Initial Report FDA Received Date: 09/28/2018
• Supplement Report FDA Received Date: 11/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1