MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 DOT PPICC PROVENA 4F DL 3CG; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	10/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the customer line is too deep (clearly on cxr and with patency issues because of) with no negative deflections on 3cg print out and vice-versa negative deflection on well placed picc tip.The patient had runs of vtach because the line was into the atrium.This picc was removed during an over the wire exchange to decrease catheter length.Lines had excellent 3cg waveforms to confirm tip location.
Additional Manufacturer Narrative
The date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of refz3340 showed two other similar product complaint(s) from this lot number.The complaints for this lot number (refz3340) have been reported from the same facility.
Event or Problem Description
It was reported by the customer line is too deep (clearly on cxr and with patency issues because of) with no negative deflections on 3cg print out and vice-versa negative deflection on well placed picc tip.The patient had runs of vtach because the line was into the atrium.This picc was removed during an over the wire exchange to decrease catheter length.Lines had excellent 3cg waveforms to confirm tip location.Additional information received: a double lumen picc was placed without incident to right arm of patient for long term antibiotics.Cath was trimmed to 50cm after measuring external landmarks, patient in nsr, no pacemaker, no ectopy, no artifact on ecg, able to clear line at bedside with 3cg technology with maximal p wave amplitude and no negative p wave deflection.That night patient had runs of vtach during ambulation or repositioning in bed.A cxr was ordered and line was in right atrium.Vascular access services replaced line with a shorter picc in the am.It was stated a statlock securement device was used.No migration after insertion, external length at 0cm.The patient is being treated for osteomyelitis.
Additional Manufacturer Narrative
H11: section a through f - 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.

• Brand Name: DOT PPICC PROVENA 4F DL 3CG
• 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
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 15782480
• Report Number: 3006260740-2022-05032
• Device Sequence Number: 6676038
• Product Code: LJS
• UDI-Device Identifier: 00801741213304
• UDI-Public: (01)00801741213304
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K180548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2022

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 Expiration Date: 03/31/2023
• Device Model Number: N/A
• Device Catalogue Number: CK000992
• Device Lot Number: REFZ3340
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/23/2022
• Supplement Date Received by Manufacturer: 12/16/2022
• Initial Report FDA Received Date: 11/11/2022
• Supplement Report FDA Received Date: 12/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Unknown
• Patient Weight: 83 KG