MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERGLIDE PRO MIDLINE CATHETER (20G) (10CM); CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of refv1538 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported via ms&s " caller states she is a home health nurse working with a patient that has a powerglide midline product code f120101t (refv1538).Caller states she took off the dressing for the device and the catheter was kinked.She states she adjusted the catheter and reinserted it a little back into the vein.Caller states she cannot get a blood return from this midline.Caller asking what is bd's recommendation for re-inserting the midline.Should i give the patient antibiotics?" ms&s explained that bd does not have a recommendation to reinsert a midline catheter if some of the catheter slides out.Discussed blood flow in the veins of the upper arms.Midline catheters are peripheral catheters.Blood return in midlines is not an indication that the midline is in or out of the vein.Explained that she should follow her facility's protocol for midlines and how to proceed.This should include contacting the physician for further guidance.Imaging the catheter may be necessary.

• Brand Name: POWERGLIDE PRO MIDLINE CATHETER (20G) (10CM)
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• 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: 13488505
• Report Number: 3006260740-2022-00210
• Device Sequence Number: 17445819
• Product Code: FOZ
• UDI-Device Identifier: 00801741142727
• UDI-Public: (01)00801741142727
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K162377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/29/2022

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: F120101T
• Device Lot Number: REFV1538
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2022
• Initial Report FDA Received Date: 02/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown