MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 DOT 3FR SL PROV ML; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	SP4153108DB
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/25/2020
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 reeq0652 showed one other similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same facility.
Event or Problem Description
It was reported a defect was found with an introducer, not allowing it to thread in easily.Additional information received via medwatch "vat nurse placing a midline, unable to thread in introducer, even after nicking the patient, introducer removed and that is when the defect was noticed, a new midline kit opened to retrieve second introducer, no issues after using new introducer.It was reported this occurred twice.This report addresses the second event.

• Brand Name: DOT 3FR SL PROV ML
• 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: 11065115
• Report Number: 3006260740-2020-21061
• Device Sequence Number: 13613735
• Product Code: PND
• UDI-Device Identifier: 00801741185076
• UDI-Public: (01)00801741185076
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K153393
• 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): 12/21/2020

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: 04/30/2021
• Device Model Number: SP4153108DB
• Device Catalogue Number: SP4153108DB
• Device Lot Number: REEQ0652
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2020
• Initial Report FDA Received Date: 12/23/2020
• 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