MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C. GEM V/NV CKV 3 SS 20DP 20PK; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	ME1048
Medical Device Problem Codes	Backflow (1064); Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that the 12 in non-dehp minibore extension set experienced leakage and component separation.The following information was provided by the initial reporter: piv was placed using the bd maxguard extension set.Less than 30 minutes later patient notified nurse that it was "leaking".Upon evaluation is was noted that blood was leaking from the connection site of the extension set and iv hub.It seems the extension set became loose from the hub, although screwed on tightly and taped down.Extension set was changed out with a different brand.
Additional Manufacturer Narrative
The following field has been corrected: b.3 date of event: (b)(6) 2020 device evaluation: a complaint of leakage on model me1048 was received.No product or photo was returned by the customer.The customer complaint of leakage could not be verified due to the product not being returned for failure investigation.A device history record review for model me1048 lot number 20045633 was performed.The search showed that a total of (b)(4) in 1 lot number was built on 08apr2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.
Event or Problem Description
It was reported that the 12 in non-dehp minibore extension set experienced leakage and component separation.The following information was provided by the initial reporter: piv was placed using the bd maxguard extension set.Less than 30 minutes later patient notified nurse that it was "leaking".Upon evaluation is was noted that blood was leaking from the connection site of the extension set and iv hub.It seems the extension set became loose from the hub, although screwed on tightly and taped down.Extension set was changed out with a different brand.

• Brand Name: GEM V/NV CKV 3 SS 20DP 20PK
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.; blvd. insurgentes 20351; tijuana, null 22244 ; MX 22244
• MDR Report Key: 10342078
• Report Number: 9616066-2020-02345
• Device Sequence Number: 19047626
• Product Code: FPA
• UDI-Device Identifier: 10885403236006
• UDI-Public: 10885403236006
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2020

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: Other
• Device Expiration Date: 04/08/2025
• Device Catalogue Number: ME1048
• Device Lot Number: 20045633
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/29/2020
• Supplement Report FDA Received Date: 09/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other