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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SALTER LABSETCO2 DIVIDED SAMPLING CANNULA

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SALTER LABS ETCO2 DIVIDED SAMPLING CANNULA   Back to Search Results
Model Number 4707F
Event Date 10/23/2012
Event Type  Other   Patient Outcome  Other
Event Description

On (b)(6) 2012, salter labs vp ra/qa observed an adverse event reported via the maude database. According to the maude event report, the 'input of the o2 portion" of a divided cannula "became loose and fell away¿causing the [patient] not to be hooked to the o2. No harm came to the [patient], however, this was a concern". Additionally, the event report states that "[salter labs] was contacted to notify company about this issue;" however, salter labs has no record of having received a complaint matching this description or lot number described in the event. Once receiving notification via maude database, this complaint was formerly entered into the complaint handling system. The (b)(6) was contacted to confirm it is not possible to determine the contact info for the initial reporting facility. The (b)(6) confirmed initial reporter info is confidential. Records for this par number, lot number, indicate that the lot of product in question went to a number of customers and an even larger number of customer locations. Therefore, it is not possible to determine which customer/subsidiary customer likely filed the complaint and also not possible to determine the pt status or whether product can be returned for evaluation. As the product in question has not been returned to salter labs for evaluation and there is no add'l product belonging to that part number, lot number in inventory for salter labs to perform an eval, it is not possible to confirm the failure and/or determine the root cause of the failure. This is a final report.

 
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Brand NameETCO2 DIVIDED SAMPLING CANNULA
Type of DeviceSAMPLING CANNULA
Manufacturer (Section F)
SALTER LABS
arvin CA
Manufacturer (Section D)
SALTER LABS
arvin CA
Manufacturer (Section G)
Manufacturer Contact
colleen moyna, manager
100 west sycamore rd.
arvin , CA 93203
(661) 854 -6862
Device Event Key2963588
MDR Report Key2913039
Event Key2809555
Report Number2921601-2013-00001
Device Sequence Number1
Product CodeCCK
Report Source Manufacturer
Source Type Other
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 01/08/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/08/2013
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL Number4707F
Device Catalogue Number4707F
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? No
Date Manufacturer Received12/18/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? Yes
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Invalid Data

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