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

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 09/17/2014

Event Type  malfunction  

Event Description

The event is reported as: the distributor (b)(4) alleges that a torn package was observed during incoming inspection.A total of (2) packages were observed with this reported issue.

Manufacturer Narrative

No visual or functional inspection can be performed since the device sample is not available for eval.The device history record (dhr) of the product (b)(4) with lot # 02b1400691 was reviewed and was found that an ncmr was opened for rejection due to damage during transit.Complete lot was inspected at 100% visual inspection.The product was re-inspected and re-packed however this type of defect is easy to be detected during the manufacturing of the product since it is verified at 100%.Additionally, per internal procedure, distribution center performs 100% inspection.Dhr 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 product damage.No conclusion can be established at this time based on the lack of the device sample.It is necessary the physical sample in order to perform a proper investigation.If the product sample becomes available, this complaint will be reopened.However, manufacturing and r & d departments are evaluating the current packaging design, k a proposal of a new packaging method has been identified, and therefore, a process/design has been initiated.Personnel involved in the manufacturing process have been notified on this issue.

• Brand Name: HUDSON NEBULIZER ADAPTOR 033, STERILE, JAPANESE
• Type of Device: NEBUIZER ADAPTOR
• Manufacturer (Section D): TELEFLEX MEDICAL; rtp NC 27709
• Manufacturer (Section G): TELEFLEX MEDICAL; ave. industrias no.5954; parque industrial finsa; nuevo laredo, tamaulipas ; MX
• Manufacturer Contact: margie burton, rn ; po box 12600; durham, NC 27709 ; 9194334965
• MDR Report Key: 4172789
• MDR Text Key: 5098938
• Report Number: 3004365956-2014-00366
• 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: 09/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2014
• 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: 09/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1