MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC 5 F POLYURETHANE CATHETER NURSING BASIC TRAY W/MICROINTRODUCER 55CM; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number N/A

Device Problems Crack (1135); Fluid/Blood Leak (1250)

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

Event Date 05/31/2023

Event Type  malfunction  

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 manufacturer has received the sample and will evaluate.Results are expected soon.

Event Description

It was reported, "the catheter hub appears to have cracked where there is leakage of administered solutions.The catheter had to be changed." no other information was provided.

Event Description

It was reported, "the catheter hub appears to have cracked where there is leakage of administered solutions.The catheter had to be changed." 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.Based on a review of available complaint information and an evaluation of the available sample evidence, the following was concluded: the complaint of leakage at the luer/accessory interface was confirmed; however, the root cause was not identified.The product returned for evaluation was two photographs and one segment of digital video which depicted a single-lumen powerpicc catheter.The first photograph depicted the luer.A 3-way petcock was attached to the luer adapter.The catheter appeared to be inserted into the arm of a patient.The second photograph depicted a closer view of the luer with the accessory removed.The video depicted the catheter being flushed through the petcock.A dripping leak was observed at the interface between the luer and the accessory.Leakage was visible in the video; however, inspection of the photographs and the video was insufficient to identify the cause of the leak.Consequenlty this complaint is confirmed as ¿cause unknown¿ at this time.Potential contributing factors include luer damage and use of an incompatible accessory.H3 other text : evaluation findings are in section h.11.

• Brand Name: POWERPICC 5 F POLYURETHANE CATHETER NURSING BASIC TRAY W/MICROINTRODUCER 55CM
• 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 17131808
• MDR Text Key: 317222277
• Report Number: 3006260740-2023-02442
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741027666
• UDI-Public: (01)00801741027666
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K033389
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2023
• 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: 3175118
• Device Lot Number: REGW0822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2022
• 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