MAUDE Adverse Event Report: TELEFLEX HUDSON NEBULIZER ADAPTOR 028, STERILE, SHELFPAK

Catalog Number 031-28

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 (31) 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 evaluation.The device history record (dhr) of the product (b)(4) with batch number (b)(4) was 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 shows that the product was assembled and inspected according to our specifications.During the investigation it was found that component tfx-000354 (sheet foam) batch (b)(4) and (b)(4) were used during the manufacturing process, to prevent product damage.Additionally, per internal procedure, distribution center performs 100% inspection as well as 100% inspection during manufacturing.No conclusion can be established at this time based on the lack of device sample.It is necessary to evaluate the physical sample in order to perform a proper investigation.If the product sample becomes available this complaint will be re-opened.However, manufacturing and r&d departments are evaluating the current packaging design, a proposal of a new packaging method has been identified, and therefore a process/design validation has been initiated.Personnel involved on the manufacturing process were notified on this issue.

• Brand Name: HUDSON NEBULIZER ADAPTOR 028, STERILE, SHELFPAK
• Type of Device: NEBULIZER ADAPTOR
• Manufacturer (Section D): TELEFLEX; rtp NC 27709
• Manufacturer (Section G): TELEFLEX MEDICAL; ave. industrias no.5954; parque industrial finsa; nuevo laredo, tamaulipas 8827 5; MX 88275
• Manufacturer Contact: margie burton, rn ; p.o. box 12600; durham, NC 27709 ; 9194334965
• MDR Report Key: 4172803
• MDR Text Key: 20780942
• Report Number: 3004365956-2014-00365
• 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: 031-28
• Device Lot Number: 02C1402447
• 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: 03/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1