MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERLOC SAFETY INFUSION SET 20G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 8652034

Device Problem Failure to Infuse (2340)

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

Event Date 03/15/2021

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of asdys0042 showed three other similar product complaint(s) from this lot number.

Event Description

It was reported before performing the maintenance of the infusion port for the patient, routinely flush the infusion tube needle and find that the pipeline is blocked.

• Brand Name: POWERLOC SAFETY INFUSION SET 20G X 0.75IN
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• 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: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 11644947
• MDR Text Key: 244873431
• Report Number: 3006260740-2021-01263
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741048333
• UDI-Public: (01)00801741048333
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K060812
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/20/2021

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
• Device Operator: Health Professional
• Device Model Number: 8652034
• Device Catalogue Number: 8652034
• Device Lot Number: ASDYS0042
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/19/2021
• Initial Date FDA Received: 04/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2019
• 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