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
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3006260740-2023-02442
• Device Sequence Number: 6457687
• Product Code: LJS
• UDI-Device Identifier: 00801741027666
• UDI-Public: (01)00801741027666
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K033389
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2025
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2023
• Supplement Date Received by Manufacturer: 10/11/2023
• Initial Report FDA Received Date: 06/14/2023
• Supplement Report FDA Received Date: 10/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown