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).A visual, dimensional, and functional inspection of the device involved in the complaint could not be conducted since the device or a picture of the alleged defect was not provided.The device history record (dhr) has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.All materials used during the assembly met current specifications.Dhr shows that the product was assembled and inspected according to our specifications.Customer complaint cannot be confirmed due the lack of device sample to perform a proper investigation to confirm the alleged defect and determine the root cause.Root cause is unknown.No corrective actions can be assigned at this time.If the sample becomes available this report will be updated with the evaluation results.Teleflex will continue to monitor and trend for complaints of this nature.

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)(6) one device of subassembly ph12161 028 intl neb adaptor phantom holder (subassembly is part of the fg 403128 adaptor, 028 neb, intl) was received for analysis.Visual inspection findings consistent with signs of use.Device not in original packaging, pin protector missing.Also, during visual inspection it was observed that component p/n tfx-001743 doesn't spin freely.Sample was tested on the dual station lift test, and general pull and push test procedures with no functional issues.However, during the setup of the oxygen entrainment test it was observed that the assembly of the nut adaptor component p/n tfx-001743 and the upper body component p/n mp-0527 was unstable.Even with that condition, the sample was able to be tested on oxygen entrainment testing with no functional issues.(continued) other remarks: after the testing, the component p/n tfx-001743 was carefully disassembled from the component upper body mp-0527 and it was visually inspected.During the visual inspection it was found wear on its internal tabs.As an additional test, with the unstable connection on the assembly, the sample was assembled with a sterile water 381-52 reservoir, concha mini 760 ml and tested according oxygen entrainment testing.Attempts to duplicate the failure mode were performed and there are two ways to duplicate them: the first one is by overtightening the nut adaptor p/n tfx-001743 into the flow meter.The second one is by manipulating the assembly connection.The complaint is confirmed.However, there is no sufficient evidence that this issue originated during the manufacturing assembly or molding process.The wear on the internal tabs of component tfx-001743 most likely be caused by the end user during the connection of the adaptor into the flowmeter that causes an unstable connection.The personnel of the assembly line were notified on for awareness.Teleflex will continue to monitor customer feedback for complaints of this nature.

• 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: 7596595
• MDR Text Key: 110965344
• Report Number: 3004365956-2018-00183
• 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: 05/24/2018

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: 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
• Initial Date Manufacturer Received: 05/24/2018
• Initial Date FDA Received: 06/13/2018
• Supplement Dates Manufacturer Received: 07/20/2018
• Supplement Dates FDA Received: 07/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OXYGEN DISPENSER; OXYGEN DISPENSER; OXYGEN DISPENSER