MAUDE Adverse Event Report: TELEFLEX MEDICAL PLASTIC NIPPLE & NUT,INTL; TUBING, PRESSURE AND ACCESSORI

Catalog Number 42555

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/26/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the user was unable to connect the nipple & nut to an oxygen tube as the connection was loose.Therefore, a new unit was used instead.No patient harm reported.

Manufacturer Narrative

Qn# (b)(4).The sample was returned for evaluation.A visual inspection was performed and it was observed that the assembly of the nut and nipple is loose as described in the complaint.Damage was found on the internal tabs of the nut.No other issues were found.The device history record of batch number 74h1900109 was reviewed and no issues or discrepancies were found which could potentially be related to this complaint.No non conformance reports were originated for the lot in question that can be associated to the complaint reported.The dhr shows that the product was assembled and inspected according to specifications.Based on the investigation performed, the reported complaint is confirmed.Although the complaint is confirmed , there is not e nough evidence to assure that this issue was originated during the manufacturing assembly or molding process.The damage on the internal tabs of nut were most likely caused by the end user during the connection of the nut into the flowmeter.The root cause for the condition reported could not be identified.

Event Description

It was reported that the user was unable to connect the nipple & nut to an oxygen tube as the connection was loose.Therefore, a new unit was used instead.No patient harm reported.

• Brand Name: PLASTIC NIPPLE & NUT,INTL
• Type of Device: TUBING, PRESSURE AND ACCESSORI
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 10267478
• MDR Text Key: 199127734
• Report Number: 3004365956-2020-00140
• Device Sequence Number: 1
• Product Code: BYX
• 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: 06/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 42555
• Device Lot Number: 74H1900109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• Date Manufacturer Received: 07/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED; NONE REPORTED