MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 105" ADMIN SET 20DP, W/Y SITE CLAMPS; INTRAVASCULAR ADMINISTRATION SET

Model Number	B2-70071-D
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that the 105" admin set 20dp, w/y site clamps tubing was found "crimped" below the drip chamber.The following information was provided by the initial reporter: "an administration set model: b2-70071-d; lot: 20025258 set was crimped below the drip chamber.Operator pharmacy technician.Medication normal saline.No patient involved.Patient was not harmed on 6-19-2020." "performed a visual inspection, and it was confirmed that the tubing was crimped below the drip chamber.".
Additional Manufacturer Narrative
H6: investigation summary: it was reported that an administration set was crimped below the drip chamber b2-70071-d-105" admin set 20dp, w/y site clamps-na (kink), no sample was provided by the customer.Only photos were provided by customer.A device history review was conducted for lot number 20025258 no qns were reported for lot 20025258.No functional evaluation was required since the defect is visually detected.No dimensional evaluation was required since the defect is visually detected.A visual inspection was performed at tijuana to the photos provided by the customer.The kink failure mode was confirmed.H3 other text : see h.10.
Event or Problem Description
It was reported that the 105" admin set 20dp, w/y site clamps tubing was found "crimped" below the drip chamber.The following information was provided by the initial reporter: "an administration set model b2-70071-d lot 20025258 set was crimped below the drip chamber.Operator pharmacy technician.Medication normal saline.No patient involved.Patient was not harmed.(b)(6) 2020." "performed a visual inspection, and it was confirmed that the tubing was crimped below the drip chamber.".

• Brand Name: 105" ADMIN SET 20DP, W/Y SITE CLAMPS
• Common Device Name: 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: 10939368
• Report Number: 9616066-2020-20513
• Device Sequence Number: 4295333
• Product Code: FPA
• UDI-Device Identifier: 00814371020150
• UDI-Public: 00814371020150
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2021

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 Expiration Date: 02/05/2023
• Device Model Number: B2-70071-D
• Device Catalogue Number: B2-70071-D
• Device Lot Number: 20025258
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/09/2020
• Supplement Date Received by Manufacturer: 01/18/2021
• Initial Report FDA Received Date: 12/03/2020
• Supplement Report FDA Received Date: 01/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1