MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 6 IN NON-DEHP MICROBORE BI-FUSE SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	ME1001
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	03/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that 6 in non-dehp microbore bi-fuse set was cracked and leaked.The following information was provided by the initial reporter: it was reported by the customer that leaking was noted on bed sheets coming from picc tubing.Blood backed up into picc extension and into tubing.Upon removal of the tubing, the bi-fuse tubing was noted to be cracked at the y of the bi-fuse extension piece.
Additional Manufacturer Narrative
H.6.Investigation: no product or photo was returned by the customer.The customer complaint of crack with leak 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 me1001 because a lot number was not provided by the customer.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.H3 other text : see h.10.
Event or Problem Description
It was reported that 6 in non-dehp microbore bi-fuse set was cracked and leaked.The following information was provided by the initial reporter: it was reported by the customer that leaking was noted on bed sheets coming from picc tubing.Blood backed up into picc extension and into tubing.Upon removal of the tubing, the bi-fuse tubing was noted to be cracked at the y of the bi-fuse extension piece.

• Brand Name: 6 IN NON-DEHP MICROBORE BI-FUSE 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
• MDR Report Key: 12089632
• Report Number: 9616066-2021-51421
• Device Sequence Number: 4752195
• Product Code: FPA
• UDI-Device Identifier: 10885403235948
• UDI-Public: 10885403235948
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 07/01/2021

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
• Operator of Device: Other
• Device Catalogue Number: ME1001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/02/2021
• Supplement Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 06/29/2021
• Supplement Report FDA Received Date: 07/20/2021
• 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