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

Catalog Number 1613

Device Problem Crack (1135)

Patient Problem No Patient Involvement (2645)

Event Date 06/13/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a crack was found in the circuit prior to set-up during leak testing.No patient involvement.

Event Description

It was reported that a crack was found in the circuit prior to set-up during leak testing.No patient involvement.

Manufacturer Narrative

Qn#(b)(4).One sample, product code 1613 , ventilator tubing set , long length was received for investigation.Upon receipt the circuit set was visually inspected for any signs of abuse/misuse/damage.At close examination a "slice" was detected, measuring approximately 1/2 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.Visual inspection confirmed the slice in the tubing.The slice does not appear to be associated with a manufacturing process.It appears that something came in contact with the tubing set that was sharp, perhaps a box cutter or scalpel.Perhaps the tubing set was cut while unpacking a shipping container.The complaint has been confirmed, but a root cause cannot be established.

• Brand Name: VENTILATOR TUBING SET,LONG LENGTH
• Type of Device: CIRCUIT, BREATHING (W CONNECTO
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8822122
• MDR Text Key: 152057645
• Report Number: 3004365956-2019-00193
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 06/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2019
• 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: 07/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1