MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 DOT PG PRO 20G 8CM FULL; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	F120081
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of refp0144 showed no other similar product complaint(s) from this lot number.Device not returned for evaluation.
Event or Problem Description
It was reported "the guidewire broke off inside a patient during attempted midline placement.This has resulted in the patient having to have surgery and multiple imaging studies." additional information received 06/14/2021: "was there patient harm reported?: yes.Had to have multiple imaging studies to search for the wire and had surgery.They were never able to retrieve it.".

• Brand Name: DOT PG PRO 20G 8CM FULL
• 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: 12092249
• Report Number: 3006260740-2021-02479
• Device Sequence Number: 14597741
• Product Code: FOZ
• UDI-Device Identifier: 00801741110573
• UDI-Public: (01)00801741110573
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K153280
• 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): 06/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: F120081
• Device Catalogue Number: F120081
• Device Lot Number: REFP0144
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/09/2021
• Initial Report FDA Received Date: 06/30/2021
• 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: Required Intervention
• Patient Age: 54 YR
• Patient Weight: 65