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

Catalog Number UNKNOWN

Device Problem No Display/Image (1183)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/19/2021

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and is pending evaluation.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 picc is not dense enough for x-ray placement.No other information was provided.

Event Description

It was reported picc is not dense enough for x-ray placement.No other information was provided.

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, sample analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of low visibility of the catheter was confirmed but the cause is unknown.A single x-ray of the patient¿s chest was returned for evaluation of this complaint.A catheter could be seen in the image but there was low visibility of the catheter and its position.The image was forwarded to a radiologist consultant for further review.The main conclusion from the radiologist was that a picc was visible in the x-ray with the tip of the catheter being at the level of the distal svc.As per the radiologist, the catheter can be seen better with certain techniques and positioning that moves the catheter from overlying the spine.In addition, a portable technique and larger body habitus can be contributing factors that make the picc more difficult to see.The exact cause of the low visibility of the catheter could not be determined but may have been affected by multiple factors including patient position, anatomy of the patient, radiographic technique, and catheter size.H3 other text : evaluation findings are in section h.11.

• 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: 11645120
• MDR Text Key: 244887127
• Report Number: 3006260740-2021-01270
• 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: company representative,other
• Type of Report: Initial,Followup
• Report Date: 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2021
• Date Manufacturer Received: 05/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other