MAUDE Adverse Event Report: TELEFLEX HUDSON CIRCUIT,PEDIATRIC,SINGLE HTD LIMB W/WAT; BREATHING CIRCUIT

Catalog Number 780-23

Device Problems Break (1069); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 03/06/2014

Event Type  malfunction  

Event Description

The event is reported as: the customer alleges that the circuit was found broken at the connection to the wye connector.The alleged issue was detected prior to pt use.

Manufacturer Narrative

Two pictures of the unit of catalog number 780-23 (circuit, pediatric, single htd limb w/wate) were rec'd for analysis.They were visually inspected founding that the cuff had a tear.A dimensional and dimensional 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 02g1201687 that belong to catalog number 780-23 has been reviewed and no issues or discrepancies were found which could potentially relate 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.A certificate of compliance for the lot of corrugated tube used on the manufacture of this batch was reviewed, finding that the coc does not specify the material mix percentages used to manufacture this lot of product; it only states that virgin material (no regrind) was used to manufacture this lot, however after scar was open a clarification was done to the vendor requesting a mixture of 91%ldpe - 9%eva (virgin material only / no regrind permitted).This requirement was requested to be included on the coc as a confirmation that production was done according to specifications.Also, teleflex drawing was updated with this requirement.After these changes were completed, 2 more lots of tube were rec'd (94897 & 95246) and aged tested with no issues reported during the age tested.Based on pictures rec'd, customer complaint is confirmed.

• Brand Name: HUDSON CIRCUIT,PEDIATRIC,SINGLE HTD LIMB W/WAT
• Type of Device: BREATHING CIRCUIT
• Manufacturer (Section D): TELEFLEX; nuevo laredo ; MX
• Manufacturer Contact: margie burton, rn ; p.o. box 12600; durham, NC 27709 ; 9194334965
• MDR Report Key: 3869089
• MDR Text Key: 4456088
• Report Number: 3004365956-2014-00169
• Device Sequence Number: 1
• Product Code: CAG
• 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
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 780-23
• Device Lot Number: 02G1201687
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1