MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 7-DAY LL VLV ADPT(STAND ALONE); INTRAVASCULAR ADMINISTRATION SET

Catalog Number 2000E7D

Device Problem Leak/Splash (1354)

Patient Problem Exposure to Body Fluids (1745)

Event Date 12/01/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device lot #: the customer provided lot # 1016664.This does not match the catalog number provided.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).

Event Description

It was reported that 7-day ll vlv adpt (stand alone) leaked.The following information was provided by the initial reporter: connector that leaks through the input port.Additional information received on 09.Dec.2020 ((b)(6), 11.Dec.2020): there was no patient injury.The event happened after device use.There was blood exposure.

Event Description

It was reported that 7-day ll vlv adpt (stand alone) leaked.The following information was provided by the initial reporter: connector that leaks through the input port.Additional information received on 09.Dec.2020 (b)(6), on (b)(6) 2020): there was no patient injury.The event happened after device use.There was blood exposure.

Manufacturer Narrative

H.6.Investigation: no samples were received for investigation of complaint in which the customer has indicated that leakage was observed "through the input port" of a 2000e7d.The customer was unsure of the lot number but has suggested that it may have been 1016664.No further information was available to assist the investigation in this instance.The root cause of the customer¿s experience could not be determined as the sample was not available for investigation.In this instance, without a sample it is not possible to determine whether a manufacturing defect could have caused or contributed to the reported fault.A review of the production records for lot: 1016664 did not identify any in-process testing failures or quality deviations which may have caused or contributed to a report of this nature.

• Brand Name: 7-DAY LL VLV ADPT(STAND ALONE)
• 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: 11092236
• MDR Text Key: 231786448
• Report Number: 9616066-2020-20679
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2000E7D
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/01/2020
• Initial Date FDA Received: 12/29/2020
• Supplement Dates Manufacturer Received: 01/18/2021
• Supplement Dates FDA Received: 01/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other