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

Catalog Number 031-28

Device Problem No Flow (2991)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 08/03/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).No functional inspection can be performed since the device sample is not available for evaluation.Failure mode could not be duplicated since is unknown the reason why the adaptor is not spraying sterilized water, however functional test was performed on 30 subassembly (p/n: 12136) and no issues or discrepancies were found.The test consisted on (b)(4) pieces (p/n: 12136 lot number: 74j1500563) from which a visual inspection and oxygen flowmeter inspection was conducted and the devices performed according to specification.A device history record review could not be conducted since the lot number was not provided.No conclusion can be established at this time based on the lack of a device sample.Root cause is unknown.If the device sample becomes available this complaint will be reopened.

Event Description

The customer alleges that the water could not be sprayed out from the nebulizer adaptor.No patient injury reported.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the internal threads of the adaptor were damaged.In order to investigate the reported defect from the customer, the sample was connected to an oxygen supply (even with the damaged thread issue on the adaptor) , and also was assembled with a sterile water concha mini bottle.During the testing the sample did nebulize.The issue reported by the customer could be caused by the damage on the internal thread of the adaptor, which could not allow it to be properly connected to the oxygen supply.Based on the investigation performed, the reported complaint was confirmed.The root cause for the issue is the positioning of the thread lead and the softness of the new resin used for the snap adaptor.A capa was opened to address this issue.

Event Description

The customer alleges that the water could not be sprayed out from the nebulizer adaptor.No patient injury reported.

• Brand Name: HUDSON NEBULIZER ADAPTOR 028,SHELFPAK
• Type of Device: ADAPTOR
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 5070607
• MDR Text Key: 26075563
• Report Number: 3004365956-2015-00284
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Followup
• Report Date: 08/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 031-28
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/11/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/06/2015
• 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: Initial
• Patient Sequence Number: 1