MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. V/NV BURETTE SET; INTRAVASCULAR ADMINISTRATION SET

Model Number	82113E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's address is unknown.(b)(6) has been used as a default.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that v/nv burette set was cracked.The following information was provided by the initial reporter: material no: 82113e, batch no: 18025628.It was reported that the body of the buretrol was squeezed and it cracked.
Additional Manufacturer Narrative
H.6.Investigation: a sample was returned for investigation.Through visual inspection of the sample, the cusomter complaint was verified.A device history record review for model 82113e lot number 18025628 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A complaint history check was performed and this is the 2nd related complaint reported with the defect/condition of component damage with no leak with lot #18025628 regarding item #82113e.The root cause of this defect was determined to be misuse of product.See h.10.
Event or Problem Description
It was reported that v/nv burette set was cracked.The following information was provided by the initial reporter: material no: 82113e batch no: 18025628 it was reported that the body of the buretrol was squeezed and it cracked.

• Brand Name: V/NV BURETTE SET
• 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: 10652460
• Report Number: 9616066-2020-20041
• Device Sequence Number: 11403495
• Product Code: FPA
• UDI-Device Identifier: 37613203009608
• UDI-Public: 37613203009608
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K780130
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2020

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 Expiration Date: 02/12/2021
• Device Model Number: 82113E
• Device Catalogue Number: 82113E
• Device Lot Number: 18025628
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2020
• Initial Date Received by Manufacturer: 09/16/2020
• Supplement Date Received by Manufacturer: 10/21/2020
• Initial Report FDA Received Date: 10/08/2020
• Supplement Report FDA Received Date: 11/10/2020
• 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