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

Catalog Number 8173118

Device Problems Fluid/Blood Leak (1250); Material Rupture (1546)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/27/2021

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of redx1299 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported at the moment of the procedure, while preparing the material and opening the package, it was noticed a rupture of the extension of the catheter by visual analysis.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, 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 a leak is inconclusive due to poor sample condition.Two photo samples of a 3 fr powerpicc sv catheter were provided for evaluation.The first photo shows the catheter outside of patient use and is laid out on a desk surface.The catheter appears to be trimmed and the stylet is visible extending past the distal end of the catheter.A kink is present near the 7 cm depth marker.The second photo appears to show the catheter in the same condition as the first photo.The bend in the catheter appears to be sharp.The condition of the catheter surface could not be clearly inspected to confirm the presence of a split or additional surface damage.The severe bend in the stylet may have been caused during handling and may have contributed to the reported damage in the catheter.Since the catheter could not be physically tested for leaks and no apparent damage was noted on the surface, the complaint could not be confirmed and remains inconclusive at this time.H3 other text : evaluation findings are in section h.11.

Event Description

It was reported at the moment of the procedure, while preparing the material and opening the package, it was noticed a rupture of the extension of the catheter by visual analysis.No other information was provided.

• Brand Name: POWERPICC SV 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: 11382233
• MDR Text Key: 234940981
• Report Number: 3006260740-2021-00499
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• PMA/PMN Number: K102159
• 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: 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: 8173118
• Device Lot Number: REDX1299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2021
• Date Manufacturer Received: 04/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other