MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC PROVENA; 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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a picc that was placed on saturday, 3cg looks good.On sunday there was occlusion issues so a cxr was ordered and it clearly shows picc tip very much in the right atrium.The line was pulled back 4cm as recommended by radiologist and post repositioning cxr showed tip in cavo-atrial junction.
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of refz3340 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (refz3340) have been reported from the same facility.
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.The following were reviewed as part of this investigation: patient severity, complaint and batch history, applicable previous investigation(s), applicable manufacturing records, image analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint that the 3cg tcs placed picc was too deep was inconclusive due to the sample condition.A sherlock 3cg tcs ecg printout and a radiographic image were returned for evaluation.The tcs printout showed both the external and intravascular waves.The tcs printout was unremarkable and appeared appropriate.The frontal chest radiograph showed a right-sided picc with its tip either at the cavoatrial junction or even below the lower edge of the radiograph.The exact tip location was difficult to interpret due to the increased density over the heart and mediastinum in that area, interstitial prominence and median sternotomy wires.The exact location of the tip of the catheter could not be determined from the returned cxr and therefore this complaint will be recorded as inconclusive.However, based on the description that an occlusion was felt, it is likely that the tip was malpositioned and was advanced too far.Possible contributing factors for the catheter advancement could include the movement due to catheter securement method or advancement due to the anatomy of the heart and the size of the svc, right atrium and ivc.
Event or Problem Description
It was reported a picc that was placed on saturday, 3cg looks good.On sunday there was occlusion issues so a cxr was ordered and it clearly shows picc tip very much in the right atrium.The line was pulled back 4cm as recommended by radiologist and post repositioning cxr showed tip in cavo-atrial junction.

• Brand Name: POWERPICC PROVENA
• 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: 15755037
• Report Number: 3006260740-2022-04405
• Device Sequence Number: 15033230
• 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: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2022

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: 03/31/2023
• Device Model Number: N/A
• Device Catalogue Number: CK000992
• Device Lot Number: REFZ3340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 12/13/2022
• Initial Report FDA Received Date: 11/08/2022
• Supplement Report FDA Received Date: 12/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Other
• Patient Sex: Unknown