MAUDE Adverse Event Report: AVID MEDICAL C-SECTION PACK; OBSTETRICAL KIT

Catalog Number HSAM00405

Device Problems Moisture Damage (1405); Device Packaging Compromised (2916)

Patient Problem No Information (3190)

Event Date 02/14/2017

Event Type  malfunction  

Event Description

A cesarean pack was opened and there was moisture found to be in the blood tube, and the towels and lap sponges were damp.Due to wetness/moisture present, the sterility of the pack was compromised.All packs from lot number were pulled and hospital supply company was notified.An avid medical complaint form was completed.

• Brand Name: C-SECTION PACK
• Type of Device: OBSTETRICAL KIT
• Manufacturer (Section D): AVID MEDICAL
• MDR Report Key: 6399106
• MDR Text Key: 69893988
• Report Number: MW5068407
• Device Sequence Number: 1
• Product Code: OKV
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/09/2017

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: HSAM00405
• Device Lot Number: 1218060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/09/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1