MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON ADAPTOR,028 NEB,INTL; NEBULIZER

Catalog Number 403128

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/24/2015

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 device was not returned.The device history record of the product 403128 with batch number 74c1503424 has been reviewed and no issues or discrepancies were found that could potentially relate to this complaint.No conclusion can be established at this time based on the lack of device sample.It is necessary to evaluate the device sample in order to perform a proper investigation.If the device sample becomes available this complaint will be reopened.Customer complaint cannot be confirmed due to the lack of product sample to perform a proper investigation and determine the root cause.If the device sample becomes available this investigation will be updated with the evaluation results.

Event Description

The customer alleges that there was a water leakage around the connection part between the adaptor and aquapak.A new kit was obtained.No patient injury.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the sample appeared to be used and the puncture pin protector was missing.No other issues were found.Functional testing was performed and the sample passed all tests.The sample received is a subassembly (part number 12136) that is not part of the finished good (part number 403128).Also, the sample received functioned properly; therefore, the complaint could not be confirmed.

Event Description

The customer alleges that there was a water leakage around the connection part between the adaptor and aquapak.A new kit was obtained.No patient injury.

• Brand Name: HUDSON ADAPTOR,028 NEB,INTL
• Type of Device: NEBULIZER
• 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: 5144031
• MDR Text Key: 28037066
• Report Number: 3004365956-2015-00313
• 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
• Type of Report: Followup
• Report Date: 09/28/2015

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 Expiration Date: 04/30/2020
• Device Catalogue Number: 403128
• Device Lot Number: 74C1503424
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/12/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2015
• 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