MAUDE Adverse Event Report: CFN MEXICO 215 SA DE CV EXT SET W/VLV PORT & LL; INTRAVASCULAR ADMINISTRATION SET

Model Number	30204E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical 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 ext set w/vlv port & ll clamp did not occlude the tube and allowed dripping.The following information was provided by the initial reporter: we are having an issue with 30204e set iv extension 8in 1-port were the clamp is not occluding the tube and allowed dripping.It¿s unclear to us if this is lot number based or an issue with the product as a whole.
Event or Problem Description
It was reported that the ext set w/vlv port & ll clamp did not occlude the tube and allowed dripping.The following information was provided by the initial reporter: we are having an issue with 30204e set iv extension 8in 1-port were the clamp is not occluding the tube and allowed dripping.It¿s unclear to us if this is lot number based or an issue with the product as a whole.
Additional Manufacturer Narrative
One photo was returned by the customer.No product was returned by customer.The customer complaint of the slide clamp not occluding the tubing could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on model 30204e because a lot number was not provided by the customer.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.

• Brand Name: EXT SET W/VLV PORT & LL
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): CFN MEXICO 215 SA DE CV; parque industrial el florido.; tijuana, null 22244 ; MX 22244
• MDR Report Key: 10200871
• Report Number: 9616066-2020-02011
• Device Sequence Number: 2246531
• Product Code: FPA
• UDI-Device Identifier: 10885403235177
• UDI-Public: 10885403235177
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K960280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2020

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 Model Number: 30204E
• Device Catalogue Number: 30204E
• Device Lot Number: UNKNOWN
• 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: 06/26/2020
• Supplement Report FDA Received Date: 10/09/2020
• 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