MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC PROVENA 5F TL; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	S1395108
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2020
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 rees1282 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 the customer has a 5fr.Provena triple picc that migrated to the neck.Additional information received 12/09/2020: it was stated the cxr showed loop in catheter in the upper chest area cathflow and power flushing not effective picc pulled back and made into a midline.
Event or Problem Description
It was reported the customer has a 5fr.Provena triple picc that migrated to the neck.Additional information received 12/09/2020: it was stated the cxr showed loop in catheter in the upper chest area cathflow and power flushing not effective picc pulled back and made into a midline.
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), labeling, applicable manufacturing records, x-ray analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a catheter tip malposition was inconclusive due to the sample condition.Two x-rays were returned for evaluation of this complaint.The first x-ray is labeled ¿f.Rtl #rees1282 friday¿ and the second x-ray is labeled ¿friday 11/20¿.Both x-rays were of a partial torso and were grainy and unclear.The images were forwarded to a radiologist consultant for further review.As per the radiologist, ¿essentially nondiagnostic images.The catheters are seen in the region of the right subclavian and the proximal right internal jugular vein and not overlying the svc, but i can not see the tip.¿ as the catheter tip location could not be discerned in the returned x-rays, this complaint is inconclusive at this time.Based on the description of the reported event, possible contributing factors could include the patient¿s anatomy, insertion or securement technique, or the catheter whipping during power injection.H3 other text : evaluation findings are in section h.11.

• Brand Name: POWERPICC PROVENA 5F TL
• 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: 11061891
• Report Number: 3006260740-2020-21048
• Device Sequence Number: 11564998
• Product Code: LJS
• UDI-Device Identifier: 00801741112744
• UDI-Public: (01)00801741112744
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2021

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 Model Number: S1395108
• Device Catalogue Number: S1395108
• Device Lot Number: REES1282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2020
• Initial Date Received by Manufacturer: 12/01/2020
• Supplement Date Received by Manufacturer: 02/18/2021
• Initial Report FDA Received Date: 12/23/2020
• Supplement Report FDA Received Date: 03/18/2021
• 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: Other