MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 22 GAUGE POWERGLIDE PRO MIDLINE CATHETER 8CM BASIC KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	F122080
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2021
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 reew4254 showed no similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "pt having midline placed in picc suite by experienced iv rn with assist rn assist.Catheter, needle and wire stuck ( powerglide pro midline catheter 22g 8cm lot#reew4254) unable to be retracted from pt's vessel, and catheter breaking from hub.Assist rn activated rrt while procedure rn placed a clamp on catheter to prevent migration.Rrt requested tourniquet remain on arm, catheter be held with clamps and provider be notified and request for vascular surgery consult stat to bedside.Arm x-ray completed to assess for catheter integrity vs migration.Pt reassured of safety by iv and rrt rns.Warm blanket applied to left forearm in event that vessel spasm may have contributed to inability to retract catheter/wire.Provider ( dr.) came to bedside and vascular surgery team initially requested this be completed by ir, however both ir providers are in procedures with estimated length of time to completion > 30 min.Vascular surgery called again by dr.And they came to bedside to assist.Dr.Did remove the catheter intact from pt.'s vessel.It did come apart at the hub, but the catheter was removed intact otherwise.Guidewire and needle also appear to be intact.Further of concern is the pt.Was pending discharge today after placement of line.Picc rns unable to visualize several major vessels in the bilateral upper arms with ultrasound and attempted in one visualized vessel of each upper arm, but unable to thread the wire.Thus the plan for forearm powerglide.Picc team has no further treatment options available.Request for pt.To have line placed by ir.As it is friday, and after 4pm , ir initially declined line placement.Advocacy for plan to discharge patient home given and hospital volume, ed volumes and need for inpatient beds discussed as rationale for not delaying this procedure for pt.Who can be discharged home pending line placement.Dr.Agreed to take pt.For ir explore for upper arm midline.D6b called and pt being transported to ir for line placement,.Dr.Attempted to contact for plan to proceed with discharge, however she is no longer on call.The covering grid person received the page when dr.Entered in web paging.Dr.Notified of this and he (working from offsite) is in contact with another provider to attempt to remedy the call sign in issue as well as figure out who could continue the process of discharging this patient.The progress note from today/discharge note is not in the chart as of this time.Dr.Not available.(5:30pm) she did spend a significant amount of time at bedside and coordinating the consults and request for access of this patient.Fall back plan is that person covering patient tomorrow could continue plan for discharge.".

• Brand Name: 22 GAUGE POWERGLIDE PRO MIDLINE CATHETER 8CM BASIC KIT
• 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
• MDR Report Key: 12184285
• Report Number: 3006260740-2021-02820
• Device Sequence Number: 19939663
• Product Code: FOZ
• UDI-Device Identifier: 00801741110542
• UDI-Public: (01)00801741110542
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K162377
• 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): 06/29/2021

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: F122080
• Device Catalogue Number: F122080
• Device Lot Number: REEW4254
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/23/2021
• Initial Report FDA Received Date: 07/16/2021
• 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: 36 YR
• Patient Weight: 105