MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PG PRO 22G 8CM BASIC KIT; 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 device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of recx2080 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
The picc nurse at the facility reported, "placing a 22 g power glide midline lot number recx2080 when the device failed.I advanced the guide wire and when attempting to advance the ¿wings¿ i could feel a metal on metal grinding sensations in my finger tips.At this point i attempted to withdraw the entire system.It felt like just the ¿body¿ withdrew however, and when i looked down at the tip there was no needle only the guide wire.The needle and safety lock device were still embedded with the catheter in the skin.I was able to successfully get the needle out of the catheter, however at this point i had bloody 8cm needle.".

• Brand Name: PG PRO 22G 8CM BASIC KIT
• 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: 8533664
• Report Number: 3006260740-2019-01125
• Device Sequence Number: 18910114
• Product Code: FOZ
• UDI-Device Identifier: 00801741110542
• UDI-Public: (01)00801741110542
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K153280
• 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): 04/19/2019

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 Model Number: N/A
• Device Catalogue Number: F122080
• Device Lot Number: RECX2080
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2019
• Initial Report FDA Received Date: 04/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1