MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SV CATHETER 4F FULL TRAY (DUAL-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 Consequences Or Impact To Patient (2199)
Date of Event	12/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation, as the device was discarded after the event occurred.A lot history review (lhr) of redu3050 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
4 fr double lumen powerpicc placed in the right upper arm, brachial vein, 10 cm external length; securacath in place.It was reported that insertion procedure stop time was 1805 on 12/21/19.Picc was flushed with heparin 10 units/ml 1 ml to both lumens.At 1825, the bedside rn attempted to obtain blood from the red port but was unable to aspirate blood.She attempted to flush with a heparinized saline syringe and immediately noted fluid leaking from under the securacath.Confirmed with the rn who inserted the picc that the catheter was properly aligned within the channel of the securacath.The external catheter length was 10 cm, so the reverse taper would have been outside of the securacath.The picc flushed easily without resistance when it was heparinized post-insertion.

• Brand Name: POWERPICC SV CATHETER 4F FULL TRAY (DUAL-LUMEN)
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9649463
• Report Number: 3006260740-2020-00317
• Device Sequence Number: 19554338
• Product Code: LJS
• UDI-Device Identifier: 00801741027826
• UDI-Public: (01)00801741027826
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K102159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/30/2020

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: 3274108
• Device Lot Number: REDU3050
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2020
• Initial Report FDA Received Date: 01/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 7 YR
• Patient Weight: 20