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 08/28/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the product was not received at our facility.The device history record of batch number 74c1503092 that belong to catalog number 031-33j has been reviewed and no issues or discrepancies were found which could potentially be related to this complaint.Records reviewed showed that there were no issues related to functional issues on the molded component involved in this complaint (b)(4) (snap-on flowmeter adaptor) batch # 1-1215741, 7-1115742 & 1-1215742.No corrective action can be established at this moment since the device sample or pictures are not available for evaluation.Customer complaint cannot be confirmed based only on the information provided, to perform an investigation and determine the source of defect reported it is necessary to evaluate the sample involved in this complaint.An attempt to duplicate the failure mode was made but at the time there is no inventory of the involved product code available at the facility and it is not being manufactured at the time.If device sample becomes available at a later date this complaint will be re-opened.

Event Description

The customer alleges that the snap on the flowmeter adaptor didn't fit with the oxygen flowmeter.A new kit was obtained.

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.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 snap on the flowmeter adaptor didn't fit with the oxygen flowmeter.A new kit was obtained.

• 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: 5074866
• MDR Text Key: 26134884
• Report Number: 3004365956-2015-00279
• 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: 08/31/2015

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: 03/28/2020
• Device Catalogue Number: 031-33J
• Device Lot Number: 74C1503092
• 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: 09/14/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/06/2015
• 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