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

Catalog Number 031-33J

Device Problem Connection Problem (2900)

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

Event Date 07/01/2015

Event Type  malfunction  

Event Description

The customer alleges that the connector was easily stripped and unable to connect with the flow rate.

Manufacturer Narrative

(b)(4).No visual or functional inspection can be performed since the device sample was not returned for evaluation.A device history record review could not be conducted since the lot number was not provided.Customer complaint cannot be confirmed, based on the lack of the device sample.It is necessary to have the physical sample in order to perform a properly investigation.If the device sample becomes available this complaint will be reopened.An attempt to duplicate the failure mode was made, but at the time there is no inventory of the involved product code (031-033j: nebulizer adaptor 033 , sterile,japanese) available at the facility.However regarding other customer complaints from this same issue, a capa file #(b)(4) was opened to perform a further investigation this issue.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the thread on the adaptor was damaged.Based on the visual exam, the reported complaint was confirmed.A capa was opened to address the issue with the adaptors.

Event Description

The customer alleges that the connector was easily stripped and unable to connect with the flow rate.

• Brand Name: HUDSON NEBULIZER ADAPTOR 033,STERILE,JAPANESE
• 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: 4939175
• MDR Text Key: 6038724
• Report Number: 3004365956-2015-00190
• 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: Foreign,Health Professional,User Facility,Company Representative,company represent
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2015
• 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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/02/2015
• 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