MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 DOT PROV SOLO 4F DL MAX; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of reew1856 showed one other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported via medwatch " attempted to insert a bard provena 4fr picc catheter on a patient.The sherlock device was detecting signal while the picc line was being advance into the patient.The picc tip was finally detected and it showed that it was pointing up into the patients's (b)(6).No resistance was felt throughout the procedure.However, when the picc line was retracted for repositioning a "click" was felt.The procedure was then aborted, and the catheter was found intact, but the 3cg stylet appeared to be sheared off.A chest x-ray was immediately ordered and found 2cm portion of the 3cg stylet in the patient's right ventricle.".

• Brand Name: DOT PROV SOLO 4F DL MAX
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 11421676
• Report Number: 3006260740-2021-00620
• Device Sequence Number: 3976516
• Product Code: LJS
• UDI-Device Identifier: 00801741130373
• UDI-Public: (01)00801741130373
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K180548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/07/2021

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: N/A
• Device Catalogue Number: S1294108D
• Device Lot Number: REEW1856
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2021
• Initial Report FDA Received Date: 03/05/2021
• 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