MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO2 CATHETER 4F MAXIMAL BARRIER TRAY WITH MICROINTRODUCER (SINGLE-LU; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 reep3980 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported via ms&s: "currently purchase product 9194108d, 4fr picc line single lumen, from you.Today i was placing a picc line on 355 and i was able to insert the t-adaptor and i advanced the {icc line cath 20cm and was not able to advanced any more.I pulled out the cath line and when i pulled the t adaptor the tip was missing.I had to order cxr and ct of the chest to see if the tip was left in the arm or lungs.Dr.Was not able to see it in the images.I don't know if this is a mechanical problem from the kits.".

• Brand Name: POWERPICC SOLO2 CATHETER 4F MAXIMAL BARRIER TRAY WITH MICROINTRODUCER (SINGLE-LU
• 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: 10290909
• Report Number: 3006260740-2020-02556
• Device Sequence Number: 825870
• Product Code: LJS
• UDI-Device Identifier: 00801741035609
• UDI-Public: (01)00801741035609
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/17/2020

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 Expiration Date: 07/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 9194108D
• Device Lot Number: REEP3980
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2020
• Initial Report FDA Received Date: 07/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1