MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. GIBECK HUMID-VENT FILTER, SMALL; BREATHING CIRCUIT BACTERIAL FILTER

Catalog Number 19502EU

Device Problems Gas/Air Leak (2946); Material Integrity Problem (2978)

Patient Problem Hypoventilation (1916)

Event Date 07/05/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that "fully fragmented anaesthesia humid vent bacterial filter caused leakage during surgery.The device had passed the inspection (leak) with that filter.Requested single volume 500ml, of which volume of air inhaled 500ml and volume of air exhaled is reduced approx.By half.The patient's oxygen saturation had time to decrease and the co2 to rise slightly before the situation was noticed.The patient has not been harmed by the incident.The filter had already been fragmented when removed from the package, but the staff did not noticed this during the leak test.".

Event Description

It was reported that "fully fragmented anaesthesia humid vent bacterial filter caused leakage during surgery.The device had passed the inspection (leak) with that filter.Requested single volume 500ml, of which volume of air inhaled 500ml and volume of air exhaled is reduced approx.By half.The patient's oxygen saturation had time to decrease and the co2 to rise slightly before the situation was noticed.The patient has not been harmed by the incident.The filter had already been fragmented when removed from the package, but the staff did not noticed this during the leak test.

Manufacturer Narrative

(b)(4).Corrected data: section d.1.-brand name corrected to gibeck humid-vent filter, small.Section d.4.-catalog# updated to 19502eu.The lot# is unknown.The sample was returned for evaluation.A visual exam was performed and it was observed that the housing was cracked.Based on the visual exam, the complaint is confirmed.The crack could be due to high force applied on the device, or mishandling of the device by the user.It was reported by the user facility that "the device had passed the inspection (leak) with that filter." the defect is very obvious and can be seen by the naked eye.The ifu for this product mentions not to use if the package is broken or the product is damaged.There has been no change of material for the product since the product was introduced to the market.In the current manufacturing procedure, 100% leak testing and visual inspection is conducted after the assembly process, thus any defective product would be detected prior to release from the manufacturing facility.

• Brand Name: GIBECK HUMID-VENT FILTER, SMALL
• Type of Device: BREATHING CIRCUIT BACTERIAL FILTER
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• MDR Report Key: 10380157
• MDR Text Key: 202063377
• Report Number: 8040412-2020-00158
• Device Sequence Number: 1
• Product Code: CAH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 19502EU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2020
• Initial Date Manufacturer Received: 07/17/2020
• Initial Date FDA Received: 08/07/2020
• Supplement Dates Manufacturer Received: 09/03/2020
• Supplement Dates FDA Received: 09/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.; NONE REPORTED.
• Patient Outcome(s): Other