MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON ISO-GARD FILTER STR STERILE; BACTERIAL FILTER

Catalog Number G19211

Device Problems Leak/Splash (1354); Component Missing (2306)

Patient Problem Death (1802)

Event Date 02/14/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).It is unknown if the device sample is available for evaluation.Telelfex has requested additional information regarding the incident and device availability.To date, no additional customer information received.

Event Description

A respiratory insufficient patient, in advanced age, was found with primary mechanical decoupling.Resuscitation was started immediately.The patient was intubated and ventilated manually with ambu and iso-gard filter attached.A leakage was noted.Tube position was checked and the filter was removed.The locking cap of the co2 port was missing.Resuscitation was unsuccessful and the patient expired.

Manufacturer Narrative

(b)(4).A device history record (dhr) review was performed on the lot number reported by the customer and there were no issues found that could relate to the reported complaint.The sample was not returned for evaluation; therefore, (b)(4) pieces of the same catalog number were selected from current production at the manufacturing facility.A visual exam was performed on all (b)(4) samples and no defects were observed.Functional testing was also performed and the samples all passed the leak test.In the current manufacturing procedure, 100% leak testing is conducted after the assembly process; thus, any defects would be detected prior to release.As no actual sample was returned for investigation, the complaint of "co2 port cap missing" could not be confirmed.A 'product ship hold notification' was initiated on the complaint lot to ensure there are no products with a missing cap.In addition, a briefing was conducted with the operators at the manufacturing facility to ensure the luer cap is assembled on the product.

Event Description

A respiratory insufficient patient, in advanced age, was found with primary mechanical decoupling.Resuscitation was started immediately.The patient was intubated and ventilated manually with ambu and iso-gard filter attached.A leakage was noted.Tube position was checked and the filter was removed.The locking cap of the co2 port was missing.Resuscitation was unsuccessful and the patient expired.

• Brand Name: HUDSON ISO-GARD FILTER STR STERILE
• Type of Device: BACTERIAL FILTER
• Manufacturer (Section D): TELEFLEX MEDICAL; perak, west malaysia
• Manufacturer (Section G): TELEFLEX MEDICAL; po box 28, kamunting industrial estate; perak, west malaysia 34600 ; MY 34600
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 5491710
• MDR Text Key: 40030743
• Report Number: 8040412-2016-00038
• Device Sequence Number: 1
• Product Code: CAH
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: G19211
• Device Lot Number: 15JT21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2015
• 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
• Patient Outcome(s): Death