MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 PPICC BASIC 3CG; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number N/A

Device Problems Fluid/Blood Leak (1250); Insufficient Flow or Under Infusion (2182)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/10/2021

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 that the patient had a power picc placed on (b)(6) 2021.Chemotherapy was started on (b)(6), started infusion with infusion pump on (b)(6).It was noticed that the dripping of medication got poorer on (b)(6) and leakage was found at insertion site and removed the catheter on (b)(6) 2020.Latest, oncovin, and saline solution was used.There was no reported patient injury.

Event Description

It was reported that the patient had a power picc placed on (b)(6) 2021.Chemotherapy was started on (b)(6) 2021, started infusion with infusion pump on (b)(6) 2021.It was noticed that the dripping of medication got poorer on (b)(6) 2021, and leakage was found at insertion site and removed the catheter on (b)(6) 2020.Lastet, oncovin, and saline sloution was used.There was no reported patient injury.

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 a leak in the catheter was unconfirmed as the problem could not be reproduced on the returned sample.The product returned for evaluation was a 5fr d/l powerpicc catheter.The catheter had been trimmed distal of the 38cm depth marking.The print on both extension legs was slightly worn.The 26cm and 27cm depth markings were slightly worn on the catheter shaft.Small amounts of usage residue were seen throughout the sample.Tactile evaluation of the sample was unremarkable except for a small amount of curved shape memory in the catheter shaft.Measurements were taken of the catheter tubing at the distal end and were compared to the device specifications.The outer diameter, lumen wall thickness, and septum wall thickness were within the device specifications.An attempt was made to flush the catheter with water from a 12cc luer-lock syringe.Both catheter lumens were patent to infusion and no leaks were detected.The distal end of the catheter was then clamped with atraumatic hemostats and the catheter was flushed against the occlusion, pressurizing the sample.No leaks were detected when the sample was pressurized.As no leaks were detected, this complaint will be considered unconfirmed at this time.

• Brand Name: PPICC BASIC 3CG
• 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: 11286093
• MDR Text Key: 231658463
• Report Number: 3006260740-2021-00244
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• PMA/PMN Number: K051672
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2021
• 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: 1275118J
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2021
• Date Manufacturer Received: 03/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other