MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON NEBULIZER ADAPTOR 033,STERILE,JAPANESE; NEBULIZER (DIRECT PATIENT INTE

Catalog Number 031-33J

Device Problem Connection Problem (2900)

Patient Problem No Patient Involvement (2645)

Event Date 01/11/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device involved has not been received by the manufacturer for evaluation at the time of this report.The device history record (dhr) of batch number 74c1702469 has been reviewed and no issues or discrepancies were found which could p otentially relate to this complaint.Dhr shows that the product was assembled and inspected according to our specifications.The device sample is needed for a proper and thorough investigation.Customer complaint cannot be confirmed based on the information provided at this time.Root cause cannot be determined.Corrective actions cannot be assigned.If the device sample becomes available this report will be updated with the evaluation results.

Event Description

Customer complaint alleges "when the user tried to attach the adaptor to the flowmeter, it was so unstable that the adaptor came off.Therefore, it was replaced with a new unit".There was no patient involvement reported.

Event Description

Customer complaint alleges "when the user tried to attach the adaptor to the flowmeter, it was so unstable that the adaptor came off.Therefore, it was replaced with a new unit".There was no patient involvement reported.

Manufacturer Narrative

Qn#(b)(4).The sample was returned for evaluation.A visual exam was performed and no issues 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, however the sample passed the testing.After the testing was finished, the nut adaptor was carefully disassembled from the upper body and it 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 is most likely caused by the end user during the connection of the adaptor into the flowmeter that causes an unstable connection issue.

• Brand Name: HUDSON NEBULIZER ADAPTOR 033,STERILE,JAPANESE
• Type of Device: NEBULIZER (DIRECT PATIENT INTE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8274651
• MDR Text Key: 134061942
• Report Number: 3004365956-2019-00018
• 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: 01/11/2019

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 Expiration Date: 03/22/2022
• Device Catalogue Number: 031-33J
• Device Lot Number: 74C1702469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2019
• Initial Date Manufacturer Received: 01/11/2019
• Initial Date FDA Received: 01/24/2019
• Supplement Dates Manufacturer Received: 02/28/2019
• Supplement Dates FDA Received: 02/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FLOW METER.; FLOW METER.