MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 FULL KIT 20G X 8 CM WITH BIOPATCH; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	F320088T
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of reey2980 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "powerglide pro catheter broke in patient body.Dr had to surgically remove remaining catheter." no other information was provided.Additional information received 05/11/2021: it was reported by health professional "i filled out a midas with the event.The patient is still in the unit if additional information is needed for pt name, etc.The line was being inserted and while advancing the catheter resistance was met so when the wire was pulled back there was more resistance so when i removed the device i noted that there was partial catheter intact.I palpated and felt what was suspected to be the retained catheter in the skin.A tourniquet was placed lightly in the axilla region and the dr was paged immediately.Catheter was removed at bedside with minimal harm but could have potentially been harmful.The catheter was in the patients subcutaneous area rather than all the way in the vein.The patient was being treated originally for cancer and has since had more go on.The patient had difficult vasculature which is why a powerglide was chosen.No infectious diseases noted for patient.All of the missing catheter was also retrieved we used a measuring tape to be positive.".

• Brand Name: FULL KIT 20G X 8 CM WITH BIOPATCH
• 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: 11866444
• Report Number: 3006260740-2021-01952
• Device Sequence Number: 14349964
• Product Code: FOZ
• UDI-Device Identifier: 00801741140723
• UDI-Public: (01)00801741140723
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 05/05/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: F320088T
• Device Catalogue Number: F320088T
• Device Lot Number: REEY2980
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2021
• Initial Report FDA Received Date: 05/21/2021
• 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: Required Intervention