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 Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 02/17/2021

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.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 "since we went to these new piccs with smaller lumens and more lines we have discovered an additional issue that maybe no one has brought to your attention.We have been doing vanco troughs for years drawing blood in the picc.We have noticed a trend of higher trough levels.Of course, at first you think you are the variable in many issues that can cause an increase in trough, by not proper flushing, not turning off pump, not getting level as a true trough etc.We did an experiment and i would like to share these results with your manufacturer.We had a patient who was receiving vanco q 12 hours.His last dose infused at 0000 and ended at 0130.We had him shut off his pump and disconnect and flush.We brought him in 1100 for a true trough.We drew blood from his picc line after flushing with 30mls normal saline and drew him peripherally.The picc line result came back as 12.2.The peripheral draw came back as 10.7.These 2 results should be identical.The hcp also stated, "we have a theory that this new material your manufacturer is using is absorbing some of the medication into the material.This can result in sub-therapeutic drug levels because the trough is not true.Therefore, not being effective against the bacteria.".

• 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
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 11474900
• MDR Text Key: 240609595
• Report Number: 3006260740-2021-00807
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/23/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/17/2021
• Initial Date FDA Received: 03/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other