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

Model Number N/A

Device Problem Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/05/2020

Event Type  malfunction  

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 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
• Type of Device: MIDLINE CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: kelsey erickson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 10839465
• MDR Text Key: 217678764
• Report Number: 3006260740-2020-20533
• Device Sequence Number: 1
• Product Code: PND
• UDI-Device Identifier: 00801741153952
• UDI-Public: (01)00801741153952
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: S4153108D
• Device Lot Number: REES2155
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 80 YR
• Patient Weight: 66