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

Catalog Number 031-33J

Device Problems Tear, Rip or Hole in Device Packaging (2385); Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/01/2014

Event Type  malfunction  

Event Description

The event is reported as: during incoming inspection by the (b)(6) reports a torn package.A total of two device were reported with this issue.

Manufacturer Narrative

Picture received from the customer file was carefully reviewed.The sample presented a torn package.The device history record of the product with lot #02b1400691 was reviewed and was found that an ncmr was opened; (b)(6) rejection was due to damage during transit.The product was re-inspected and re-packed, however this type of defect is easily detected during the manufacturing of the product since it is verified at 100%.Additionally, per internal procedure, distribution center performs 100% inspection as well.Dhr shows that the product was packed and inspected according to our specifications.During the investigation it was found that component tfx-00354 (sheet foam) (b)(4) was used during the manufacturing process, this sheet foam was implemented to prevent damage to the product.Based on the picture provided, customer complaint is confirmed.Manufacturing and r&d departments are evaluating the current packaging design, a proposal of a new packaging material has been identified, therefore a process/design validation has been initiated.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
• Manufacturer Contact: margie burton, rn ; p.o. box 12600; durham, NC 27709 ; 9194334965
• MDR Report Key: 4114962
• MDR Text Key: 22140399
• Report Number: 3004365956-2014-00345
• 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: 08/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2014
• 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: 02B1400691
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2014
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1