MAUDE Adverse Event Report: KIMBERLY-CLARK HEALTH CARE SINGLE SHOT EPIDURAL TRAY NDL G/W,6"EXT,LINE,LID,NACI,PV; PAIN MANAGEMENT KITS

Model Number 182003

Device Problems Device Packaging Compromised (2916); Packaging Problem (3007)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Kimberly-clark received a report stating, ¿the plastic packaging on the outside of the tray was not sealed.No contamination or exposure issues.No patient involvement.¿ (b)(4).

Manufacturer Narrative

The device history record was reviewed and documented that the product lot reported in the incident met manufacturing specifications.The device was returned to kimberly-clark for evaluation.The side of the package that is not sealed did not show evidence of exposure to the heat sealer.The investigation is on-going.Information from this incident will be included in our product complaint and mdr trend reporting systems.Ongoing analysis of trend information is used to identify the need for additional investigations.

• Brand Name: SINGLE SHOT EPIDURAL TRAY NDL G/W,6"EXT,LINE,LID,NACI,PV
• Type of Device: PAIN MANAGEMENT KITS
• Manufacturer (Section D): KIMBERLY-CLARK HEALTH CARE; 1400 holcomb bridge road; roswell GA 30076
• Manufacturer (Section G): AVENT TUCSON WEST
• Manufacturer Contact: ra/qa ; 1400 holcomb bridge road; roswell, GA 30076 ; 7705877200
• MDR Report Key: 3719632
• MDR Text Key: 4334065
• Report Number: 1033422-2014-00007
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Model Number: 182003
• Device Catalogue Number: 991093201
• Device Lot Number: 0201231786
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2013
• 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