MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON UNIVERSAL VENTILATOR TUBING SET,W/WATER; BREATHING CIRCUIT

Catalog Number 1617

Device Problems Hole In Material (1293); Leak/Splash (1354)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 04/28/2015

Event Type  malfunction  

Event Description

The customer alleges that there is a hole in the circuit which is generating a leak during the pre-testing.No patient injury reported.

Manufacturer Narrative

(b)(4).The complaint was confirmed, but the root cause is unknown.One picture of a section of the product catalog number 1617 (universal ventilator tubing set,w/water) was received for analysis.It was visually inspected founding holes on a section of the corrugated tubing.No other issues were found.A dimensional and functional inspection of the product involved in the complaint could not be conducted since the product was not returned.The device history record (dhr) of batch number 02m1300872 that belong to catalog number 1617 has been reviewed and no issues or discrepancies were found which could potentially be related to this complaint.The dhr shows that the product was assembled and inspected according to our specifications.The customer complaint was confirmed based on the visual inspection performed to the picture received, holes on a section of the corrugated tubing were detected, at present time it is not possible to determine in which part of the supply chain process the material is being damaged since this condition it is 100% tested at production line on tp-0145 (leak test).Other remarks: however the current inventory that is in (b)(4) (universal ventilator tubing set,w/water) related to this complaint notification was inspected by the defect of "hole in the circuit" as it is describe on this customer complaint, and no issues were detected.If device sample becomes available at a later date this complaint will be re-opened.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that there were holes in the corrugated tubing.Functional testing was performed and it was determined that there was an air leak.Based on the investigation performed, the reported complaint was confirmed.Dhr shows that the product was assembled and inspected according to specification.It is unknown how the circuit was handled prior to use.The investigation found no evidence to suggest a manufacturing related cause, therefore, the root cause is undetermined.

Event Description

The customer alleges that there is a hole in the circuit which is generating a leak during the pre-testing.No patient injury reported.

• Brand Name: HUDSON UNIVERSAL VENTILATOR TUBING SET,W/WATER
• Type of Device: BREATHING CIRCUIT
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 4883738
• MDR Text Key: 6063630
• Report Number: 3004365956-2015-00176
• Device Sequence Number: 1
• Product Code: CAG
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor,distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 1617
• Device Lot Number: 02M1300872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/31/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1