MAUDE Adverse Event Report: CFN MEXICO 215 SA DE CV 7-IN STD BORE BI-FURCATED EXT SET; INTRAVASCULAR ADMINISTRATION SET

Model Number	ME1247
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/27/2020
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.Device manufacture date: unknown.(b)(4).Investigation summary: no product or photo was returned by the customer.The customer complaint of the set becoming unscrewed from the connection before use 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 (b)(4) because a lot number was not provided by the customer.A root cause could not be determined due to an investigation not being able to be performed.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.Root cause analysis: the root cause of this failure was not identified as no product was returned.Investigation conclusion: no product will be returned per customer.No investigation was performed.
Event or Problem Description
It was reported that the 7-in std bore bi-furcated ext set leaked during a chemotherapy cyclophosphamide infusion.Absorbent pads were placed under the extension set, and the treatment was delayed for "about twenty minutes" as a result, but there was no impact to the patient.The following information was provided by the initial reporter: "it was reported that a small amount of leakage was seen at the engagement of bifuse extension set during an infusion of chemotherapy cyclophosphamide through secondary set.The medication was being administered using a non-bd infusion pump.It was noted that the rn had to put absorbent pads underneath the extension set due to the clinician¿s previous experience of leaks regarding the same tubing.The certified nurse educator (cne) attempted to replicate the leak, but unable to do so and instead, recommended that in future, to use the sets with caution and to have an absorbent pad underneath, in case of leaks.The treatment was delayed for about twenty minutes to allow for event reporting to cne, documentation, and replacement of the tubing.There was no patient impact.The event occurred at the oncology unit.".

• Brand Name: 7-IN STD BORE BI-FURCATED EXT SET
• 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: 10179644
• Report Number: 9616066-2020-02016
• Device Sequence Number: 2680704
• Product Code: FPA
• UDI-Device Identifier: 10885403274305
• UDI-Public: 10885403274305
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/27/2020

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: Health Professional
• Device Model Number: ME1247
• Device Catalogue Number: ME1247
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/22/2020
• 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