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

Model Number N/A

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354); Material Perforation (2205); Device Contamination with Body Fluid (2317)

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

Event Date 09/18/2020

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of redy0083 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (redy0083) have been reported from the same facility in the (b)(6).

Event Description

It was reported, "outpatient for parenteral nutrition.The patient reported an arm pain when flushing catheter.The blood was observed on the covering when patient arrived at the hospital.The catheter was functional, but the content leaked out during flushing.The catheter had to be pulled out and cannulated over the wire and it was observed that the catheter was perforated." on (b)(6) 2020-sharp instrument damage was found on the returned catheter.

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, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leaking catheter was confirmed and the cause appears to be use related.The product returned for evaluation was one 4fr s/l powerpicc catheter.The investigation findings are consistent with catheter damage caused by contact with a sharp edged instrument such as a scalpel.The returned product sample was evaluated and three splits were observed between the 34cm and 35cm depth markings.Microscopic examination of the catheter splits confirmed they were typical of contact with a sharp bladed instrument, and the characteristics observed which supported this type of failure included: ¿ the fracture surfaces were reflective in nature and contained striated patterns.This can occur due to pattern transfer of the sharpened edge typically found on a scalpel-type instrument.¿ sharply formed fracture edges ¿ planar shape to the fracture surfaces ¿ blood residue was seen on the sample which showed that the product had undergone at least some use.An examination of the catheter structure revealed no potential damage/defect related to manufacture of the product.

Event Description

It was reported, "outpatient for parenteral nutrition.The patient reported an arm pain when flushing catheter.The blood was observed on the covering when patient arrived at the hospital.The catheter was functional, but the content leaked out during flushing.The catheter had to be pulled out and cannulated over the wire and it was observed that the catheter was perforated." 12/23/2020-sharp instrument damage was found on the returned catheter.

• Brand Name: POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TIP
• 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: 11173431
• MDR Text Key: 228186214
• Report Number: 3006260740-2020-21326
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• PMA/PMN Number: K091324
• 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: 03/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• 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: 2194108
• Device Lot Number: REDY0083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2020
• Date Manufacturer Received: 03/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other