MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. EXT SET SMALLBORE TBG W/4 FEMALE LL; INTRAVASCULAR ADMINISTRATION SET

Model Number	10015817
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/21/2020
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.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 or Problem Description
It was reported that ext set smallbore tbg w/4 female ll was damaged.The following information was provided by the initial reporter: material no.: 10015817, lot no.: unknown.It was reported that there was cracking in a quadfuse set.
Additional Manufacturer Narrative
Investigation: no product or photo was returned by the customer.The customer complaint of damage 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 10015817 because a lot number was not provided by the customer.The root cause of this failure was not identified as no product was returned.H3 other text : see h.10.
Event or Problem Description
It was reported that ext set smallbore tbg w/4 female ll was damaged.The following information was provided by the initial reporter: material no.: 10015817 lot no.: unknown it was reported that there was cracking in a quadfuse set.

• Brand Name: EXT SET SMALLBORE TBG W/4 FEMALE LL
• 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: 10694542
• Report Number: 9616066-2020-20082
• Device Sequence Number: 14345171
• Product Code: FPA
• UDI-Device Identifier: 50885403234055
• UDI-Public: 50885403234055
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• 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): 10/20/2020

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 Model Number: 10015817
• Device Catalogue Number: 10015817
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/21/2020
• Supplement Date Received by Manufacturer: 10/20/2020
• Initial Report FDA Received Date: 10/17/2020
• 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