MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. GEM V/NV 20DP CKV 2SS 0.2MF LOW SORBING; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 11532269

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/02/2020

Event Type  malfunction  

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.(b)(4).

Event Description

It was reported that the gem v/nv 20dp ckv 2ss 0.2mf low sorbing experienced leakage.The following information was provided by the initial reporter: complaint 2 of 2.I was informed of a hazardous medication spill from an infusion consisting of: etoposide, vincristine, daunorubicin.Medication infusion was being administered through bd primary filter tubing: ref ¿ 11532269 this was the second instance of the aforementioned combination hazardous medication for this patient leaking from the administration tubing near the filter site.

Manufacturer Narrative

H.6.Investigation: no photo or sample was received for investigation.The customers complaint of leakage could not be verified.A device history record review could not be performed because a lot number was not provided by the customer.Due to no sample being received, the root cause of this failure remains unknown.

Event Description

It was reported that the gem v/nv 20dp ckv 2ss 0.2mf low sorbing experienced leakage.The following information was provided by the initial reporter: complaint 2 of 2 i was informed of a hazardous medication spill from an infusion consisting of: etoposide, vincristine, and daunorubicin.Medication infusion was being administered through bd primary filter tubing: ref ¿ 11532269.This was the second instance of the aforementioned combination hazardous medication for this patient leaking from the administration tubing near the filter site.

• Brand Name: GEM V/NV 20DP CKV 2SS 0.2MF LOW SORBING
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana 22244 ; MX 22244
• MDR Report Key: 11092805
• MDR Text Key: 250333940
• Report Number: 9616066-2020-20687
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403232343
• UDI-Public: 10885403232343
• Combination Product (y/n): N
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 11532269
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1