MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 4FR DL POWERMIDLINE FULL KIT; MIDLINE CATHETER

Catalog Number	P4254108
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/01/2018
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.A lot history review (lhr) of rebx1288 showed one other similar product complaint(s) from this lot number.Mw5075144.
Event or Problem Description
The power midline catheter was removed due to a reported leak of fluid and air.Once the catheter was removed it was reported that 15cm of the catheter's distal end was missing.It was reported that only 6.5cm remained connected to the hub.

• Brand Name: 4FR DL POWERMIDLINE FULL KIT
• Common Device Name: MIDLINE CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7383952
• Report Number: 3006260740-2018-00541
• Device Sequence Number: 16395582
• Product Code: PND
• UDI-Device Identifier: 00801741129278
• UDI-Public: (01)00801741129278
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K162900
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/29/2018
• Report Date (Section F): 02/07/2018

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 Catalogue Number: P4254108
• Device Lot Number: REBX1288
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/01/2018
• Event Location: Hospital
• Date Report to Manufacturer: 03/05/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/29/2018
• 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
• Date Report Sent to FDA: 02/07/2018