MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON ADAPTOR,028 NEB,INTL; NEBULIZER (DIRECT PATIENT INTERFACE)

Catalog Number 403128

Device Problems Disconnection (1171); Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/11/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer complaint alleges "the screw fitting that is connected to the oxygen dispenser does not hold, is detached and does not supply oxygen." alleged issue reported as occurred during patient use.There was no report of patient harm.No report of necessary medical intervention.Patient condition reported as "fine".

Event Description

Customer complaint alleges "the screw fitting that is connected to the oxygen dispenser does not hold, is detached and does not supply oxygen." alleged issue reported as occurred during pateint use.There was no report of patient harm.No report of necessary medical intervention.Patient condition reported as "fine".

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the adaptor and puncture pin protector were missing.Since the adaptor was missing from the returned sample, an adaptor was taken from the production line at the manufacturing facility.The device was functionally tested and no issues were encountered.The unit functioned as intended.The complaint could not be confirmed as the adaptor was not returned for evaluation.

• Brand Name: HUDSON ADAPTOR,028 NEB,INTL
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 7689591
• MDR Text Key: 114027272
• Report Number: 3004365956-2018-00224
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/27/2022
• Device Catalogue Number: 403128
• Device Lot Number: 74G1701587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2018
• Date Manufacturer Received: 08/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OXYGEN DISPENSER; OXYGEN DISPENSER; OXYGEN DISPENSER