MAUDE Adverse Event Report: DEROYAL INTERCONTINENTAL, S.R.L. UMBILICUP; CONTAINER, EMPTY, FOR COLLECTION & PROCESSING OF BLOOD & BLOOD COMPONENTS

Model Number	72-8000NS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Root cause: the true root cause cannot be determined at this time due to the lack of a sample for evaluation.Potential root causes have been identified but are not limited to the following: an end use error or an event isolated to a single reporting customer.The product's instructions for use includes a warning that "care should be exercised whenever handling sharp needles to prevent accidental needle sticks." corrective action: due to the investigation and root cause determination, a corrective action has not been identified as being necessary.Investigation summary: an internal complaint ((b)(4)) was received indicating the needle of an umbilicup (part 72-8000ns, lot unknown) pricked a healthcare provider.The sample was not returned for evaluation because the product was discarded by the end user due to contamination.Additionally, a lot number was not provided by the end user.Therefore, the complaint investigator was unable to review the work order for discrepancies that may have contributed to the reported event.Deroyal has sold (b)(4) cases of the finished good from october 4, 2017 to september 5, 2018.Each case contains (b)(4) eaches, which equates to (b)(4) eaches sold.A review of complaints for the same time period yielded no similar issues reported.This results in a complaint-to-sales ratio of (b)(4) percent.Deroyal will continue to monitor post-market feedback and will recognize in the future if this issue reoccurs.Preventive action: due to the investigation and root cause determination, a preventive action has not been taken.The investigation is complete at this time.If new and critical information becomes available, this report will be updated.
Event or Problem Description
Healthcare provider was pricked by the needle under the gray rubber.

• Brand Name: UMBILICUP
• Common Device Name: CONTAINER, EMPTY, FOR COLLECTION & PROCESSING OF BLOOD & BLOOD COMPONENTS
• Manufacturer (Section D): DEROYAL INTERCONTINENTAL, S.R.L.; km 7, autopista joaquin balagu; pisano free zone, building 49; santiago, santiago ; DR
• MDR Report Key: 7939127
• Report Number: 1060680-2018-00008
• Device Sequence Number: 16522368
• Product Code: KSR
• UDI-Device Identifier: 00749756331951
• UDI-Public: 00749756331951
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K020753
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 72-8000NS
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/05/2018
• Initial Report FDA Received Date: 10/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1