MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON VENTILATOR TUBING SET,LONG LENGTH; CIRCUIT, BREATHING (W CONNECTO

Catalog Number 1613

Device Problem Fracture (1260)

Patient Problem No Patient Involvement (2645)

Event Date 06/13/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Received one (1) 1613, ventilator tubing set, long length, for investigation.Upon receipt the tubing was visually inspected for any signs of abuse/misuse/ damage.During visual inspection, a slit was visually identified on the column side of circuit, approximately 10 inches below the wye.The slit is approximately 3/4 of an inch in length.The device history record of batch number 74m1800028 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 specifications.Based on the investigation performed, the reported complaint was confirmed.A significant "slit" was discovered in the blue tubing causing profuse leaking.The slit is very linear , which would suggest the tubing came into dangerous contact with a sharp object.Although the complaint has been confirmed, a root cause could not be established.

Event Description

The complaint is reported as: "crack found in circuit prior to set-up during leak test." no patient involvement.

• Brand Name: HUDSON VENTILATOR TUBING SET,LONG LENGTH
• Type of Device: CIRCUIT, BREATHING (W CONNECTO
• 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: 8755854
• MDR Text Key: 149928855
• Report Number: 3004365956-2019-00180
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 1613
• Device Lot Number: 74M1800028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2019
• Date Manufacturer Received: 06/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2018
• 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