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

Model Number	61450
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	10/31/2019
Type of Reportable Event	Serious Injury
Additional 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.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 or Problem 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 first of two reports.Refer to 3006646024-2019-00028 for the second 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 herself on her right forearm.
Additional Manufacturer Narrative
All information reasonably known as of 24-jan-2020 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.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical, inc.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).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical, inc.Product is defective or caused serious injury.

• Brand Name: PARACENTESIS TRAY - 15 GA X 3.25 IN. (82.55 MM) CALDWELL NEEDLE/CANNULA
• Common Device Name: DH ENDOSCOPY PARACENTESIS PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 9363153
• Report Number: 3006646024-2019-00027
• Device Sequence Number: 2166700
• Product Code: LRQ
• UDI-Device Identifier: 10680651927948
• UDI-Public: 10680651927948
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K030721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: 61450
• Device Catalogue Number: 109279402
• Device Lot Number: 0203260156
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/01/2019
• Supplement Date Received by Manufacturer: 01/06/2020
• Initial Report FDA Received Date: 11/22/2019
• Supplement Report FDA Received Date: 01/28/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention