MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. HUDSON SMOOTH-FLO WITH DOUBLE SWIVEL,STERILE; SET, TUBING AND SUPPORT,VENTILATOR

Catalog Number G22511

Device Problem Fitting Problem (2183)

Patient Problem Insufficient Information (4580)

Event Date 06/15/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that: "the adhesive of the product stuck out so that the joint did not turn smoothly".Clarification for initial information was received by the customer and it was reported that the "defect is that the connection piece has extra adhesive preventing it from setting securely".No patient injury was reported.Patient condition "unknown" at time of report.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.The manufacturing site reports "checking the previous trend from lot rejection rate (lrr) for this affected lot, there is no failure found on excessive glue as per reported.In manufacturing site, 100% inspection and leak testing was conducted to this product.The defective part will be culled out and rejected before released for shipment." 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.

Event Description

It was reported that: "the adhesive of the product stuck out so that the joint did not turn smoothly".Clarification for initial information was received by the customer and it was reported that the "defect is that the connection piece has extra adhesive preventing it from setting securely".No patient injury was reported.Patient condition "unknown" at time of report.

• Brand Name: HUDSON SMOOTH-FLO WITH DOUBLE SWIVEL,STERILE
• Type of Device: SET, TUBING AND SUPPORT,VENTILATOR
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• Manufacturer (Section G): TELEFLEX MEDICAL SDN. BHD.; lot no : pt2577 jalen perusahaan; 4 kamunting industrial estate; perak, west malaysia 34600 ; MY 34600
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 14842965
• MDR Text Key: 303149688
• Report Number: 8040412-2022-00173
• Device Sequence Number: 1
• Product Code: BZO
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: G22511
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: N/A.; N/A.