MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOT PG PRO 18G 10CM FULL; INTRAVASCULAR CATHETER

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 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 rebq0171 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
Per sales rep, the facility reported that the midline iv catheter was removed on (b)(6) 2017 due to concern of malfunction.Nurse reported that the line flushed easily but when trying to aspirate for blood return, air filled the syringe.The catheter was removed and a split/hole was noted in tubing.No patient harm was reported.

• Brand Name: DOT PG PRO 18G 10CM FULL
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6721709
• Report Number: 3006260740-2017-01064
• Device Sequence Number: 11008740
• Product Code: FOZ
• UDI-Device Identifier: 00801741110665
• UDI-Public: (01)00801741110665
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K153280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 07/18/2017

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: 02/28/2018
• Device Model Number: N/A
• Device Catalogue Number: F218101
• Device Lot Number: REBQ0171
• 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: 07/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1