MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOT PROV SOLO 3F SL MAX; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of redx4556 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that on (b)(6) 2020 during a picc placement.The nurse placing the picc was able to use the dilator without any difficulty, but had difficulty when attempting to advance with microintroducer through the skin.The microintroducer was flimsy and appeared to crinkle during attempts to advance it.The nurse also used the scalpel to nick the skin to try to advance the micro introducer (something we rarely have to do anymore).The nurse ultimately had to use a microintroducer from a mini stick kit.Minor damage was observed to the microintroducer, but there was no harm to the patient.

• Brand Name: DOT PROV SOLO 3F SL MAX
• 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: 9959076
• Report Number: 3006260740-2020-01276
• Device Sequence Number: 2827719
• Product Code: LJS
• UDI-Device Identifier: 00801741130359
• UDI-Public: (01)00801741130359
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K162441
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/14/2020

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: 12/31/2020
• Device Model Number: N/A
• Device Catalogue Number: S1193108D
• Device Lot Number: REDX4556
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2020
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2020
• Initial Report FDA Received Date: 04/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 126