MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC CATHETER 4F MAXIMAL BARRIER TRAY (SINGLE-LUMEN); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported via ms&s "technician requesting recommendations on power injecting a patient's 4f single lumen powerpicc ((b)(4)).States they had a few instances when the power injector "pops off" the patient's powerpicc when performing a power injection of ct contrast.They are not sure if they are doing something wrong and believes this is user error.Also, requesting for someone to come in and perform another in service.States they are power injecting at a max flow rate of 3-4ml/sec." ms&s response "discussed the powerpicc ifu.Inquired if they are removing the needleless connector prior to power injecting.Customer states she is unsure.Customer states they are attaching a 10ml normal saline syringe, aspirating blood and then flushing 10ml of normal saline.Inquired if they are warming the ct contrast to body temperature.Customer states they are warming the ct contrast" additional info.Received 09/23/2021: "there was nothing wrong with the kit or the power picc.The radiology staff does not have a lot of training regarding the power injector and power piccs.Nursing access the power picc for us.Since we were having issues with the tubing not staying in tact from injector to port i just wanted to verify the mls per second and see if you offered any type of training." "i didn¿t report a complaint and there was no harm to the patient.I was looking for educational information for myself and my staff.".

• Brand Name: POWERPICC CATHETER 4F MAXIMAL BARRIER TRAY (SINGLE-LUMEN)
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 12577956
• Report Number: 3006260740-2021-04133
• Device Sequence Number: 14266695
• Product Code: LJS
• UDI-Device Identifier: 00801741027581
• UDI-Public: (01)00801741027581
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K070996
• 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): 09/22/2021

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: N/A
• Device Catalogue Number: 3174108D
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/15/2021
• Initial Report FDA Received Date: 10/05/2021
• 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