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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AVANOS MEDICAL INC. PARACENTESIS TRAY - 15 GA X 3.25 IN. (82.55 MM) CALDWELL NEEDLE/CANNULA DH ENDOSCOPY PARACENTESIS PRODUCTS

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AVANOS MEDICAL INC. PARACENTESIS TRAY - 15 GA X 3.25 IN. (82.55 MM) CALDWELL NEEDLE/CANNULA DH ENDOSCOPY PARACENTESIS PRODUCTS Back to Search Results
Model Number 61450
Device Problem Physical Resistance/Sticking (4012)
Patient Problem Laceration(s) (1946)
Event Date 11/01/2019
Event Type  Injury  
Manufacturer Narrative

The actual complaint product was not returned for evaluation. The device history record for the reported lot number, 0203260156, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements. All information reasonably known as of 19-nov-2019 has been included in this health authority report. Should additional information be obtained, a follow-up health authority report will be provided. The information provided by avanos medical, inc. Represents all of the known information at this time. Avanos medical, inc. Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred. This product incident is documented in the avanos medical, inc. Complaint database and identified as complaint (b)(4).

 
Event Description

Avanos medical, inc. Received a single report that referenced two different incidences, which were associated with separate units, involving two different events. This is the second of two reports. Refer to 3006646024-2019-00027 for the first event. It was reported physician had "severely" cut herself on the scalpel in the product kit. The incident happened when trying to remove the cover off of the scalpel, the scalpel had not been used on a patient and was clean. The physician went to the emergency room (er) for treatment and was "okay" at that time. The nurse who reported the incident noted that the cover seemed difficult to remove, and when the physician applied force to remove the cover, that is when the incident occurred. The physician cut her wrist, information was not provided if it was the left wrist or right wrist.

 
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Brand NamePARACENTESIS TRAY - 15 GA X 3.25 IN. (82.55 MM) CALDWELL NEEDLE/CANNULA
Type of DeviceDH ENDOSCOPY PARACENTESIS PRODUCTS
Manufacturer (Section D)
AVANOS MEDICAL INC.
5405 windward parkway
alpharetta GA 30004
Manufacturer (Section G)
AVENT, INC.
6620 s. memorial place, suite 100
tucson AZ 85756
Manufacturer Contact
lisa clark
5405 windward parkway
alpharetta, GA 30004
4704485444
MDR Report Key9363125
MDR Text Key185108075
Report Number3006646024-2019-00028
Device Sequence Number1
Product Code LRO
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK030721
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 01/28/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/22/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/30/2020
Device MODEL Number61450
Device Catalogue Number109279402
Device LOT Number0203260156
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/06/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/19/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 11/22/2019 Patient Sequence Number: 1
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