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

Catalog Number 031-28J

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/12/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device involved, or a picture of the defect, was not received for evaluation by the manufacturer at the time of this report.The device history record (dhr) of batch number 74h1702123 has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.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 and determine the root cause.No corrective action can be established.If the sample becomes available this report will be updated with the evaluation results.

Event Description

Customer complaint alleges "the connection part assembly between the adaptor and the flowmeter was so unstable that it came off in the end".It was replaced with a new unit.No patient harm was reported.Patient condition reported as fine.

Manufacturer Narrative

Qn# (b)(4).The sample was returned for evaluation.During the visual inspection it was observed that the sample was not received in its original package and the puncture pin protector was missing.No defects were found.During the setup of the oxygen entrainment test it was observed that the assembly of the nut adaptor and the upper body component was unstable.Even with that condition, the sample was able to be tested on the oxygen entrainment testing but the testing failed.After the testing was finished, the adaptor was carefully disassembled from the upper body and was visually inspected.During the visual inspection it was found there was wear on the internal tabs.Based on the investigation performed, the reported complaint was confirmed.Although the condition was observed on the sample provided, there is not sufficient evidence to assure that this issue was originated during the manufacturing assembly or molding process.The wear on the internal tabs of the adaptor was most likely caused by the end user during the connection of the adaptor into the flowmeter that causes an unstable connection issue.

Event Description

Customer complaint alleges "the connection part assembly between the adaptor and the flowmeter was so unstable that it came off in the end".It was replaced with a new unit.No patient harm was reported.Patient condition reported as fine.

• Brand Name: HUDSON NEBULIZER ADAPTOR 028,STERILE,SHELFPAK,
• Type of Device: NEBULIZER (DIRECT PATIENT INTE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8129821
• MDR Text Key: 129455410
• Report Number: 3004365956-2018-00339
• 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: 11/12/2018

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: 08/27/2022
• Device Catalogue Number: 031-28J
• Device Lot Number: 74H1702123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2018
• Initial Date Manufacturer Received: 11/12/2018
• Initial Date FDA Received: 12/04/2018
• Supplement Dates Manufacturer Received: 01/08/2019
• Supplement Dates FDA Received: 01/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FLOWMETER.; FLOWMETER.