MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. EPIDURAL MINIPACKS SYSTEM 1; NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Catalog Number 100/391/118

Device Problem Connection Problem (2900)

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

Event Type  malfunction  

Event Description

It was reported that the suspect device disconnects easily when attached to another device component.No patient injury was reported.

Manufacturer Narrative

Manufacturing device history record review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.Customer provided the photo showing filter with disconnected luer lock.Each filter contains retention ring which is designed to hold luer lock connected with filter.Due to poor quality of photo, it is not possible to evaluate retention edge on affected filter.Supplier corrective action report (scar) was raised in past against supplier due to similar customer complaints.Based on supplier investigation report, the issue from the past were caused by rotating collar over tightening.As per instructions for use (ifu), overtightening the connection between the epidural catheter connector or needle to the male rotating collar may cause rotating collar to dislodge from filter body.However, for this reported issue no product sample was received for evaluation; therefore, the reported issue could not be confirmed.If the product is returned, the manufacturer will reopen this complaint for further investigation.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: EPIDURAL MINIPACKS SYSTEM 1
• Type of Device: NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15315293
• MDR Text Key: 305378693
• Report Number: 3012307300-2022-16576
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K090261
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/29/2022

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 Catalogue Number: 100/391/118
• Device Lot Number: 3883009
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/13/2022
• Initial Date FDA Received: 08/29/2022
• 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
• Patient Sequence Number: 1