MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD POWER MIDLINE CATHETER (5F) (DUAL-LUMEN) (20CM); CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of recz1040 showed three other similar product complaint(s) from this lot number.The complaints for this lot number (recz1040) have been reported from the same facility.
Event or Problem Description
It was reported that when attempting to place a midline, the guidewire broke and part of the broken guidewire remained in the patient.It is stated that the piece of guidewire was pulled out of the patient and an x-ray was done to ensure that no pieces remained in the patient.No other information was provided.

• Brand Name: BARD POWER MIDLINE CATHETER (5F) (DUAL-LUMEN) (20CM)
• 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: 8599619
• Report Number: 3006260740-2019-01345
• Device Sequence Number: 13998418
• Product Code: PND
• UDI-Device Identifier: 00801741147517
• UDI-Public: (01)00801741147517
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K162900
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/10/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: CK000805
• Device Lot Number: RECZ1040
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2019
• Initial Report FDA Received Date: 05/10/2019
• 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