MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 3FR SL PROVENA MIDLINE MAX BARRIER KIT; MIDLINE CATHETER

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/05/2020
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 rees2155 showed no other similar product complaint(s) from this lot number.Device not returned for evaluation.
Event or Problem Description
It was reported: "the initial midline was removed due to a missing end cap found by the nursing home.Midline was replaced with another midline.Same arm, different vein.The same arm was used for the second midline placement due to a large surgical scar on the right upper arm." what they¿re being treated for:" pneumonia and wound necrosis." what type of catheter securement was utilized? "stat lock included in midline kit.".

• Brand Name: 3FR SL PROVENA MIDLINE MAX BARRIER KIT
• Common Device Name: MIDLINE CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 10839465
• Report Number: 3006260740-2020-20533
• Device Sequence Number: 14176906
• Product Code: PND
• UDI-Device Identifier: 00801741153952
• UDI-Public: (01)00801741153952
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K153393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/31/2020

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: S4153108D
• Device Lot Number: REES2155
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/22/2020
• Initial Report FDA Received Date: 11/13/2020
• 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: Other
• Patient Age: 80 YR
• Patient Weight: 66