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

Catalog Number 3275118

Device Problem Crack (1135)

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

Event Date 06/23/2023

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 device has not been returned to the manufacturer for evaluation.

Event Description

It was reported by the customer, according to the doctor's report, the catheter was showing a fissure.According to doctor the catheter extension was punctured, it was necessary to dispense another catheter to continue the procedure.No other information provided.

Event Description

It was reported by the customer, according to the doctor's report, the catheter was showing a fissure.According to doctor the catheter extension was punctured, it was necessary to dispense another catheter to continue the procedure.No other information provided.

Manufacturer Narrative

H11: the initial complaint appeared to be a reportable occurrence.Upon receiving additional information about the event, it was determined that a reportable event had not occurred.

• Brand Name: POWERPICC 5F NURSE BASIC TRAY WITH MICROINTRODUCER (DUAL-LUMEN)
• 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: suedabba mahboobi ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 17312993
• MDR Text Key: 319413531
• Report Number: 3006260740-2023-02911
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741027918
• UDI-Public: (01)00801741027918
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K051672
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3275118
• Device Lot Number: REGV3350
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2022
• 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