MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. GIBECK H-V FILTER SMALL; BREATHING CIRCUIT BACTERIAL FILTER

Model Number IPN055737

Device Problem Crack (1135)

Patient Problem Insufficient Information (4580)

Event Date 03/14/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that "after intubation, patient was turned into the stomach position (face down) and after that there was a leak in ventilation (ventilator alert), leak was 60-80ml/single tidal volume.The cause of the leak had to be found out before starting the operation (emergency brain surgery) and the leak was fixed by changing the filter.There is a visible crack in the filter.The filter was handled properly and it did not, for example, crash into anything." multiple inquiries were made to the customer regarding the patient's current condition, if medical intervention was required, if there was any harm or injury to the patient, was the filter checked prior to use, was force applied during connection, and if any desaturation occurred.The customer did not return our requests.If additional information is received, the complaint file will be updated.

Event Description

It was reported that "after intubation, patient was turned into the stomach position (face down) and after that there was a leak in ventilation (ventilator alert), leak was 60-80ml/single tidal volume.The cause of the leak had to be found out before starting the operation (emergency brain surgery) and the leak was fixed by changing the filter.There is a visible crack in the filter.The filter was handled properly and it did not, for example, crash into anything." multiple inquiries were made to the customer regarding the patient's current condition, if medical intervention was required, if there was any harm or injury to the patient, was the filter checked prior to use, was force applied during connection, and if any desaturation occurred.The customer did not return our requests.If additional information is received, the complaint file will be updated.

Manufacturer Narrative

(b)(4).Additional information received on 20 april 2023 states that "the patient is doing fine, no problems, patient did not need any extra medication.There was a problem, the operation had to be interrupted, because the patient was in the skull holder in the stomach position and it was not possible to get there without the operating doctor giving way.The device was checked before operation and it was working properly until the ventilator started to alarm.Force was not used.No de-saturation, the ventilator compensated the leak.".One piece of representative sample was received.The sample was closely examined by visual inspection.The complaint reported that there was a leak in ventilation.No issue found on the returned representative sample.Device was assembled correctly.Based on the investigation conducted on the returned sample, the complaint on leak was not confirmed.Leak test conducted on the sample and the result show no leak.Further investigation couldn't be conducted since there is no actual sample returned.In current manufacturing procedure, 100% leak testing and visual inspection after assembly process is conducted.Thus, any ineffective products will be culled out during this process.Therefore, it is very unlikely condition at the manufacturing area that the product having leak to be released for shipment.Customer reported the product having leak.But as per visual inspection on returned sample, there is no issue found on the product.The functional test such as leak test showed the returned product did not has any functional issue.Hence, this complaint could not be confirmed.Other remarks: n/a.Corrected data: n/a.

• Brand Name: GIBECK H-V FILTER SMALL
• Type of Device: BREATHING CIRCUIT BACTERIAL FILTER
• 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 16628220
• MDR Text Key: 312136134
• Report Number: 8040412-2023-00118
• Device Sequence Number: 1
• Product Code: CAH
• Combination Product (y/n): N
• Reporter Country Code: FI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN055737
• Device Catalogue Number: 19502EU
• Device Lot Number: KMZ22A1025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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