MAUDE Adverse Event Report: CUSTOMED, INC. CUSTOMED STERILE CONVENIENCE PACKS SURGICAL; NONE

Catalog Number ATTACHMENT II

Device Problems Air Leak (1008); Device Disinfection Or Sterilization Issue (2909); Device Packaging Compromised (2916)

Patient Problem No Patient Involvement (2645)

Event Date 08/29/2014

Event Type  malfunction  

Event Description

Bubble emission leak test fail compromising the sterility of products shipped by air produced by customed inc.And distributed by pr hospital inc.And customed usa inc.The product package integrity for sterility is considered a patient health hazard.Results of the bubble emission leak test glp report are attached to this document.This product test was part of the risk assessment of capa (b)(4) opened as a response to the fda 483 observations from (b)(6) 2014.Customed product catalogs that are subjected to investigation due to this event are listed.

Manufacturer Narrative

An evaluation performed through a risk assessment identified an adverse trend regarding packaging and shipping containers in 2014.As a consequence it was conditioned the release of the products to the following preventive requirements: batch record in-process requirements.Visual inspection post-sterilization with zero defects 100%.Acceptable visual inspection after simulated shipping conditions.Acceptable internal pressurization resistance test (post sterilization) of unrestrained packages (burst test) of products.Acceptable bubble emission test to products (external laboratory).Shipping report regarding material released will be confirmed by qa personnel before transfer of products to distribution centers.Medwatch form fda 3500a was submitted because the bubble emission leak test fail compromising the sterility of convenience packs for surgical use produced and distributed by customed inc.(b)(6) hospital, inc.And customed usa inc.

• Brand Name: CUSTOMED STERILE CONVENIENCE PACKS SURGICAL
• Type of Device: NONE
• Manufacturer (Section D): CUSTOMED, INC.; fajardo PR
• Manufacturer (Section G): CUSTOMED, INC.; calle igualdad #7; fajardo PR 00738
• Manufacturer Contact: calle igualdad #7; fajardo, PR 00738
• MDR Report Key: 4146661
• MDR Text Key: 20322118
• Report Number: 2648727-2014-00001
• Device Sequence Number: 1
• Product Code: KDD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Unknown
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: ATTACHMENT II
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention; Disability