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

Model Number N/A

Device Problems Flushing Problem (1252); Device Dislodged or Dislocated (2923)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/18/2020

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

It was reported "patient with observed to have a retracted picc into her arm.She has a securacath in situ and no visible external line or swelling to the arm.This only became apparent when the picc was not able to be flushed, it has been in situ since end of september.Chest x ray completed prior to removing the picc.".

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, applicable previous investigation(s), labeling, x-ray analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint that the picc retracted within patient¿s arm was confirmed but the cause is unknown.A single x-ray was returned for evaluation of the complaint.The x-ray was of a patient¿s chest.A single catheter line was seen near one side of the image.The image was forwarded to a radiologist consultant for further review.As per the radiologist¿s review, ¿this is a frontal chest radiograph dated 11/16/2020.The radiograph is coned down to the right side; the picc in the right arm is circled.The catheter tip is overlying the right axilla.It is hard to tell what is happening at the right arm with the catheter.¿ the radiologist confirmed that the catheter had retracted in the patient¿s arm but stated that it was hard to tell exactly what happened from the image.

Event Description

It was reported "patient with observed to have a retracted picc into her arm.She has a securacath in situ and no visible external line or swelling to the arm.This only became apparent when the picc was not able to be flushed, it has been in situ since end of september.Chest x ray completed prior to removing the picc.".

• Brand Name: BARD PICC
• Type of Device: 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: 10992818
• MDR Text Key: 221516217
• Report Number: 3006260740-2020-20855
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2020
• Date Manufacturer Received: 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other