MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON CIRCUIT,HTD DUAL LIMB W/WATER TRAPS W/O; BREATHING CIRCUIT

Catalog Number 780-36

Device Problem Hole In Material (1293)

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

Event Date 06/25/2015

Event Type  malfunction  

Event Description

The customer alleges that a hole was detected in the device prior to patient use.

Manufacturer Narrative

(b)(4).A dimensional, visual 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 74d1500709 that belong to catalog number 780-36 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.Dhr shows that the product was assembled & inspected according to our specifications.No corrective action can be established at this moment since the device sample is not available for evaluation.No picture available.Customer complaint cannot be confirmed based only on the information provided, to perform an investigation and determine the source of defect reported it is necessary to evaluate the sample involved in this complaint.An attempt to duplicate the failure mode was made but at the time there is no inventory of the involved product code available at the facility nor is being manufactured at the time.If device sample becomes available at a later date this complaint will be re-opened.

Manufacturer Narrative

(b)(4).The reported complaint that the circuit has a hole in the circuit prior to use was confirmed through visual inspection of the returned sample.The hole was identified and noted on the expiratory limb.The device history record (dhr) of batch number 74d1500709 that belongs to catalog number 780-36 has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.The investigation found no evidence to suggest a manufacturing related cause, therefore, the root cause is undetermined.

Event Description

The customer alleges that a hole was detected in the device prior to patient use.

• Brand Name: HUDSON CIRCUIT,HTD DUAL LIMB W/WATER TRAPS W/O
• Type of Device: BREATHING CIRCUIT
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 8827 5; MX 88275
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 4903441
• MDR Text Key: 6019034
• Report Number: 3004365956-2015-00184
• Device Sequence Number: 1
• Product Code: CAG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 780-36
• Device Lot Number: 74D1500709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/24/2015
• Initial Date FDA Received: 07/09/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2015
• 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