MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOT PG PRO 20G 8CM FULL; INTRAVASCULAR CATHETER

Model Number	N/A
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/11/2017
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 device has not been returned to the manufacturer for evaluation, as the device was discarded after the event occurred.A lot history review (lhr) of rebu0855 showed no other similar product complaint(s) from this lot number.Sample discarded.
Event or Problem Description
It was reported by the sales rep that the facility reported having a powerglide that sheared off.Clinician reported that after insertion the catheter showed resistance.Stopped advancing and attempted to pull back it seamed to be stuck.Pulled the needle out and then attempted to retrieve the catheter, the catheter broke approximately 4 cm was left in patients arm.The patient was taken to ir and the catheter was removed.

• Brand Name: DOT PG PRO 20G 8CM FULL
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7000887
• Report Number: 3006260740-2017-01964
• Device Sequence Number: 19206490
• Product Code: FOZ
• UDI-Device Identifier: 00801741110573
• UDI-Public: (01)00801741110573
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/03/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: F120081
• Device Lot Number: REBU0855
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/03/2017
• 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: Required Intervention