MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON BREATHING CIRC,ANES,ADULT,1.5M (60); CIRCUIT, BREATHING

Catalog Number 351200

Device Problems Air Leak (1008); Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/22/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A visual, dimensional, and functional inspection of the device involved in the complaint could not be conducted since the device was not returned at the time of this report.A device history record review shows that the device was assembled and inspected according to our specifications.Customer complaint cannot be confirmed based only on the information provided.In order to perform a proper investigation and determine the source of alleged defect reported it is necessary to evaluate the device involved on this complaint.No corrective actions can be established at this time.If the device sample becomes available at a later date this report will be updated.

Event Description

Customer complaint alleges "during preparation before using on a patient, air leakage was confirmed and there was a crack on the tubing.Therefore, a new unit was used instead." there was no report of patient harm or consequence.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and the circuit displayed several major cracks/fractures at the wye connector.Obtaining functional test values could not be accomplished as the wye connector fractures were leaking so profusely a specific leak value cannot be obtained.The reported complaint of a leaking circuit was confirmed based upon the sample received.The returned circuit was confirmed to leak as a result of several major fractures in the wye connector.A device history record review was performed on the product with no evidence to suggest a manufacturing related cause.The defect was discovered prior to patient use at pre-test.Therefore, based upon the conditions at the time of discovery and the damage observed on the returned sample, it was determined that operational context caused or contributed to this event.

Event Description

Customer complaint alleges "during preparation before using on a patient, air leakage was confirmed and there was a crack on the tubing.Therefore, a new unit was used instead." there was no report of patient harm or consequence.

• Brand Name: HUDSON BREATHING CIRC,ANES,ADULT,1.5M (60)
• Type of Device: CIRCUIT, BREATHING
• 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: 6604353
• MDR Text Key: 76410968
• Report Number: 3004365956-2017-00229
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 351200
• Device Lot Number: 74L1601758
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2016
• 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