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 07/31/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).No visual, dimensional or 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 fitting correctly to the oxygen flow meter, however functional test was performed on (b)(4) subassembly (p/n: 12161) & no issues or discrepancies were found.The test consisted on take (b)(4) pieces from the process, visual inspection and oxygen flowmeter was used with the samples and it was found that the units performed according to specification.The device history record of the product 031-33j with batch number 74c1503091 has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.Based on similar complaints a capa file# (b)(4) was opened to further investigate this issue.No conclusion can be established at this time based on the lack of device sample.If the device sample becomes available this complaint will be reopened.

Event Description

The customer alleges that the adaptor didn't fit with the oxygen flowmeter.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.Oxygen entrainment testing could not be performed as the adaptor could not be connected correctly on the oxygen supply due the damage on the internal thread.Based on the visual exam, 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 adaptor didn't fit with the oxygen flowmeter.No patient injury reported.

• 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: 5017787
• MDR Text Key: 24545960
• Report Number: 3004365956-2015-00265
• 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: 08/07/2015

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 Expiration Date: 03/27/2020
• Device Catalogue Number: 031-33J
• Device Lot Number: 74C1503091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/20/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2015
• 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