MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON 780-18 CIRCUIT W/ COLUMN; HUMIDIFIER NEBULIZER KIT

Catalog Number 780-18KIT

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/08/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A conclusion code could not be chosen.The complaint was confirmed, but the root cause is unknown.Upon receipt of the inspiratory limb of the infant breathing circuit it was visually examined for any signs of abuse/misuse/damage.The complaint has been confirmed.The temperature probe connector has broken away from the circuit inline "t" union.A device history record review could not be conducted since the lot number was not provided.The complaint has been confirmed.Root cause cannot be established.The breakage could be the result of too much force being applied either during removal or installation of the circuit temperature probe.Trending does not indicate the issue is wide spread.No further action required.

Event Description

The customer alleges that during manipulation of the neonatal circuit it broke off right above the temperature probe.No patient injury, trauma or danger.A new circuit was obtained without issue.

• Brand Name: HUDSON 780-18 CIRCUIT W/ COLUMN
• Type of Device: HUMIDIFIER NEBULIZER KIT
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: margie burton, rn ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334965
• MDR Report Key: 5906305
• MDR Text Key: 53099192
• Report Number: 3004365956-2016-00325
• Device Sequence Number: 1
• Product Code: OGG
• 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,health
• Reporter Occupation: Respiratory Therapist
• Type of Report: Initial
• Report Date: 08/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 780-18KIT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: VENTILATOR