MAUDE Adverse Event Report: TELEFLEX MEDICAL NEBULIZER ADAPTOR 028,STERILE,SHELFPAK,; NEBULIZER (DIRECT PATIENT INTE

Catalog Number 031-28J

Device Problem Connection Problem (2900)

Patient Problem No Patient Involvement (2645)

Event Date 05/21/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

Event Description

It was reported that there was an issue with the adaptor causing an unstable connection with (b)(6) bottle and flowmeter.The adaptor was replaced with a new one.No patient involvement.

Event Description

It was reported that there was an issue with the adaptor causing an unstable connection with aquapak bottle and flowmeter.The adaptor was replaced with a new one.No patient involvement.

Manufacturer Narrative

Qn#(b)(4).One (1) unit of fg 031-28j "nebulizer adaptor 028,sterile,shelfpak," was received for analysis.Signs of use are observed since a disinfection tag is present and the sample was not received on its original package.No other issues were found.Sample was tested on oxygen entrainment test (tp-0041 rev.26) and during the setup 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 (tp-0041) but the testing failed due such condition.After the testing finished, 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.A dhr review could not be conducted since the lot number was not provided.Based on the additional inspection on the component tfx-001743 of the sample received, the complaint is confirmed.Although the condition observed on the sample provided, there is no sufficient evidence to assure that this issue was 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 issue.Based on previous statements it is not possible to establish a corrective action.

• Brand Name: NEBULIZER ADAPTOR 028,STERILE,SHELFPAK,
• Type of Device: NEBULIZER (DIRECT PATIENT INTE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8691013
• MDR Text Key: 147750474
• Report Number: 3004365956-2019-00140
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• PMA/PMN Number: K153010
• 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: 05/21/2019

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 Catalogue Number: 031-28J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2019
• Initial Date Manufacturer Received: 05/21/2019
• Initial Date FDA Received: 06/12/2019
• Supplement Dates Manufacturer Received: 06/28/2019
• Supplement Dates FDA Received: 07/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1