MAUDE Adverse Event Report: LAMININ MEDICAL PRODUCTS, INC. DEROYAL; GAUZE/SPONGE, X-RAY DETECTABLE

Catalog Number E2401

Device Problem Unsealed Device Packaging (1444)

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

Event Date 03/25/2014

Event Type  No Answer Provided  

Event Description

The end user reported that during use there was a potential seal problem in the packaging of the tip cleaner.

Manufacturer Narrative

Describe event or problem: the end user reported that during use there was a potential seal problem in the packaging of the tip cleaner.Deroyal: the sample was not returned for evaluation and the root cause could not be determined for this report.There has been one other packaging related complaint for this product in the past.It was previously determined that during the forming of the packaging, air was trapped.The air movement caused the appearance of creases in the packaging.The corrective action was to alter the tooling by adding more holes for less air to be trapped during the forming process.The product in this complaint was produced prior to the above corrective actions, so no add'l actions have been taken at this time.

• Brand Name: DEROYAL
• Type of Device: GAUZE/SPONGE, X-RAY DETECTABLE
• Manufacturer (Section D): LAMININ MEDICAL PRODUCTS, INC.; grand rapids MI
• Manufacturer Contact: courtney rinehart ; 200 debusk lane; powell, TN 37849 ; 8653622122
• MDR Report Key: 3777523
• MDR Text Key: 4441922
• Report Number: 1060680-2014-00008
• Device Sequence Number: 1
• Product Code: GDY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/18/2018
• Device Catalogue Number: E2401
• Device Lot Number: 31126677
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/25/2014
• Event Location: Hospital
• Date Report to Manufacturer: 03/25/2014
• Date Manufacturer Received: 03/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2013
• 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
• Patient Outcome(s): Other