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	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, trend 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 broken powerglide pro guidewire was confirmed; however, the root cause was not identified.The product returned for evaluation was four photographs which depicted an 18ga powerglide pro midline catheter assembly.Visible in the photographs was a portion of the catheter, which appeared to be separated from the housing and regions of guidewire.Blood residue was evident throughout the visible portions of the device.The core wire and coil wire both exhibited complete breaks.The coil wire was elongated and protruded from the detached catheter.The proximal segment of the core wire protruded from the safety cannister which appeared to be engaged over the needle tip.While extensive wire damage was evident in the submitted photographs, inspection of those photographs was insufficient to identify the root cause(s) of the damage.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.Potential contributing factors include wire retraction against the needle bevel and attempted insertion into tissue.A lot history review (lhr) of redn3918 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the guide wire and catheter threaded easily.It was stated that when the clinician went to pull back on the housing after insertion the guide wire had unraveled and was still in the catheter which was in the patient, but also still attached to the housing.The clinician pull the catheter out completely.

• 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: 8818618
• Report Number: 3006260740-2019-02129
• Device Sequence Number: 2575927
• Product Code: FOZ
• UDI-Device Identifier: 00801741140518
• UDI-Public: (01)00801741140518
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K162377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/23/2019

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 Expiration Date: 02/29/2020
• Device Model Number: N/A
• Device Catalogue Number: F318107T
• Device Lot Number: REDN3918
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2019
• Initial Report FDA Received Date: 07/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1