MAUDE Adverse Event Report: TELEFLEX HUDSON NEBULIZER ADAPTOR 033, STERILE, JAPANESE

Catalog Number 031-33J

Device Problems Unsealed Device Packaging (1444); Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 10/02/2014

Event Type  malfunction  

Event Description

The event is reported as: the distributor (imj) alleges that during incoming inspection the package was found to have a "faulty sealing." a total of 230 packages were reported for this issue.

Manufacturer Narrative

Picture received with the customer complaint file was thoroughly reviewed.The sample presented an open seal on package.No functional inspection can be performed since the device sample was not available for evaluation.The device history record with lot # 74d1400275 has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.No non-conformance reports were originated for the lot in question that can be associated to the complaint reported.The dhr (device history record) shows that the product was packed and inspected according to our specifications.During the investigation it was found that component tfx-000354 (sheet foam) batch (b)(4) was used during the manufacturing process, this sheet foam was implemented to prevent the product from damage.This type of defect is easy to be detected during the manufacturing of the product since is verified at 100%.Additionally, per internal procedure, distribution center performs 100% inspection as well.Based on the picture provided, the customer complaint is confirmed.As a corrective action a new packaging method will be implemented in order to avoid open seal in the product."r & d" has initiated this project.The involved production and quality personnel were informed about this complaint.

• Brand Name: HUDSON NEBULIZER ADAPTOR 033, STERILE, JAPANESE
• Type of Device: NEBULIZER ADAPTOR
• Manufacturer (Section D): TELEFLEX; rtp NC 27709
• Manufacturer Contact: margie burton, rn ; p.o. box 12600; durham, NC 27709 ; 9194334965
• MDR Report Key: 4208914
• MDR Text Key: 4984292
• Report Number: 3004365956-2014-00377
• Device Sequence Number: 1
• Product Code: CCQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 10/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 031-33J
• Device Lot Number: 74D1400275
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1