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

Model Number N/A

Device Problems Collapse (1099); Flushing Problem (1252); Failure to Infuse (2340)

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

Event Date 11/24/2020

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 that right after inserting catheter, catheter could not be flushed with saline.After removing catheter, the end tip of catheter was collapsed.Device used on patient and patient reported ok.Hospital used new product to the patient.Intended treatment for patient is intravenous administration of antibiotics.No damaged noted prior catheter insertion.

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, sample analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of unable to infuse is confirmed and appears to be related to the use of the device.One 5 fr dl powerpicc catheter was returned for evaluation.The catheter extended up to the 39 cm depth marker.Blood residue was present on the catheter surface.One photo sample of a 5 fr dl powerpicc catheter was also provided for evaluation and appears to correspond with the returned sample.The catheter lumens were flushed with water using a 12 ml syringe.The red lumen was found to be partially occluded.A reduced flow of red tinted fluid flowed out of the distal end of the catheter.A non-complainant wire was inserted into the occluded lumen in order to locate the obstruction.The obstruction was located near the 18 cm depth marker.The catheter was cut at the obstructed region and dried blood residue was found to be occluding the catheter lumen.Since blood residue was found to be the cause of being unable to infuse, the complaint is confirmed.H3 other text : evaluation findings are in section h.11.

Event Description

It was reported that right after inserting catheter, catheter could not be flushed with saline.After removing catheter, the end tip of catheter was collapsed.Device used on patient and patient reported ok.Hospital used new product to the patient.Intented treatment for patient is intravenous administration of antibiotics.No damaged noted prior catheter insertion.

• Brand Name: POWERPICC 5F DUAL-LUMEN CATHETER BASIC TRAY
• 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: 11023077
• MDR Text Key: 222371572
• Report Number: 3006260740-2020-20945
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/22/2021

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 Model Number: N/A
• Device Catalogue Number: 8275355
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2021
• Initial Date Manufacturer Received: 11/26/2020
• Initial Date FDA Received: 12/16/2020
• Supplement Dates Manufacturer Received: 03/24/2021
• Supplement Dates FDA Received: 03/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other