MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 STATLOCK EPIDURAL MICRO 6IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number N/A

Device Problem Restricted Flow rate (1248)

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

Event Date 05/30/2022

Event Type  malfunction  

Event Description

It was reported by the customer "tubing is not priming correctly.Priming should require 6cc of fluid.Have had 7 sets so far where they have used up to 17cc and there is still bubbling in the line.Line just doesn't prime properly" add info rcvd: no catheter securement device involved.Problem is with priming the set, so they haven t even gotten as far as connecting the patient.This report addresses the second device.

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

• Brand Name: STATLOCK EPIDURAL MICRO 6IN
• 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): DAVOL SURGICAL INNOVATIONS -9616067; ave. roberto fierro #6408; parque industrial aeropuerto; cd. juarez, chih s.a. de c.v. 32690 ; MX 32690
• Manufacturer Contact: kelsey erickson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 14875482
• MDR Text Key: 297978062
• Report Number: 3006260740-2022-02473
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741083235
• UDI-Public: (01)00801741083235
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K943038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2022
• 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: VEDML6
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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