MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 112 IN 15 DROP IV ADMINISTRATION SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MX9128
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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.
Event or Problem Description
It was reported that 2 112 in 15 drop iv administration sets experienced leakage.The following information was provided by the initial reporter: material #: mx9128, batch/ lot #: unknown.They have had issues the last couple of days with leaking from cap closest to the bag.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-02-09.H6: investigation summary: a photo/video and later a sample were provided by customer of the smartsite which was reported leaking.The video quality is not optimal and the leak is difficult to see.The set was primed and multiple infusions were ran without any leak.The male luer end was occluded and using syringe and saline, fluid was injected into the tubing to try to force a leak.Every port was tested including the port reported by customer as leaking.No leak was noticed.Multiple attempts were made to contact customer for further information as to the conditions that the leak occurred and no more details were provided.The leak was never recreated.Without an adequate photo or evidence of leak, the complaint cannot be verified and the root cause is unknown.Device history could not be checked without a lot number provided.H3 other text : see h10.
Event or Problem Description
It was reported that 2 112 in 15 drop iv administration sets experienced leakage.The following information was provided by the initial reporter: material #: mx9128 batch/ lot #: unknown.They have had issues the last couple of days with leaking from cap closest to the bag.

• Brand Name: 112 IN 15 DROP IV ADMINISTRATION 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: 11236932
• Report Number: 9616066-2021-50106
• Device Sequence Number: 3247857
• Product Code: FPA
• UDI-Device Identifier: 10885403237621
• UDI-Public: 10885403237621
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 02/07/2021

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: Other
• Device Catalogue Number: MX9128
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2021
• Initial Date Received by Manufacturer: 01/05/2021
• Supplement Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 01/27/2021
• Supplement Report FDA Received Date: 03/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1