MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON BREATHING CIRC, ANES, ADULT, 40" W/3L; ANESTHESIA BREATHING CIRCUIT

Catalog Number 359103

Device Problems Crack (1135); Connection Problem (2900)

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

Event Date 12/04/2013

Event Type  malfunction  

Event Description

The complaint was reported as: the customer alleges that a connector on the anesthesia bag for the anesthesia circuit was found cracked.No pt injury reported.

Manufacturer Narrative

Two (2) pictures of catalog number 359103 (breathing circ, anes, adult, 40" w/3l) were received for analysis.They were visually inspected finding the component p/n 10503 cracked.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 02l1100768 was reviewed and no issues or discrepancies were found related to this complaint.No non conformance reports were originated for the lot in question that can be associated to the complaint reported.The dhr shows that the product was assembled and inspected according to our specifications.The customer complaint was confirmed based on the pictures received.The root cause could be related to the molding process of the fitting adaptor (p/n 10503), a slow injection process of the resin into the mold could cause the weld line to not be strong enough, causing a crack when the fitting adaptor was stressed.Currently, this product code is running on the nl003 which is the machine that is validated under the decouple method.The actual inventory of the fitting adaptors belongs to this machine and was inspected by the defect of cracks.The lot reported was manufactured before corrective actions.

• Brand Name: HUDSON BREATHING CIRC, ANES, ADULT, 40" W/3L
• Type of Device: ANESTHESIA BREATHING CIRCUIT
• Manufacturer (Section D): TELEFLEX MEDICAL; ave. industrias no.5954; parque industrial finsa; nuevo laredo, tamaulipas ; MX
• Manufacturer (Section G): TELEFLEX MEDICAL; ave. industrias no.5954; parque industrial finsa; nuevo laredo, tamaulipas ; MX
• Manufacturer Contact: margie burton ; ave. industrias no.5954; parque industrial finsa; nuevo laredo, tamaulipas ; MX ; 9194334965
• MDR Report Key: 3784669
• MDR Text Key: 17278301
• Report Number: 3004365956-2014-00016
• 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: Foreign,User Facility,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/26/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 359103
• Device Lot Number: 02L1100768
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/26/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2011
• 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