MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 6 INCH HEP LOCK EXT SET; INTRAVASCULAR ADMINISTRATION SET

Model Number	20035E
Medical Device Problem Codes	Complete Blockage (1094); Restricted Flow rate (1248); Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/10/2020
Type of Reportable Event	Malfunction
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.(b)(4).
Event or Problem Description
It was reported that 6 inch hep lock ext set would not flush and was difficult to connect.The following information was provided by the initial reporter: event 1: material #: 20035e, batch/ lot #: unknown.It was reported that the extension set would not flush.Event 2: material #: 20035e , batch/ lot #: unknown.It was reported that the syringe was difficult to connect.Not the first time had difficulty w/item; today unable to draw blood off site w/use of 2 different luer locks, then attempted to flush extension tubing w/saline to save iv site and would not flush (in mean time, pt bleeding on floor); will not use this item again unless absolutely necessary as each time have had difficulty of some kind -pt c/o pain as tubing to stiff and pulls on iv site, difficulty getting syringe to connect.
Event or Problem Description
It was reported that 6 inch hep lock ext set would not flush and was difficult to connect.The following information was provided by the initial reporter: event 1: material #: 20035e batch/ lot #: unknown it was reported that the extension set would not flush.Event 2: material #: 20035e batch/ lot #: unknown it was reported that the syringe was difficult to connect.Not the first time had difficulty w/item; today unable to draw blood off site w/use of 2 different luer locks, then attempted to flush extension tubing w/saline to save iv site and would not flush (in mean time, pt bleeding on floor); will not use this item again unless absolutely necessary as each time have had difficulty of some kind -pt c/o pain as tubing to stiff and pulls on iv site, difficulty getting syringe to connect.
Additional Manufacturer Narrative
Investigation summary: no product or photo was returned by the customer.It was reported that the extension set would not flush, and it was reported that the syringe was difficult to connect.The customer complaints 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 20035e because a lot number was not provided by the customer.Due to no samples being received, investigations could not be performed and root causes could not be determined.

• Brand Name: 6 INCH HEP LOCK EXT 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: 10959066
• Report Number: 9616066-2020-20520
• Device Sequence Number: 14208059
• Product Code: FPA
• UDI-Device Identifier: 37613203012004
• UDI-Public: 37613203012004
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K960280
• 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): 12/11/2020

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: 20035E
• Device Catalogue Number: 20035E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/10/2020
• Supplement Date Received by Manufacturer: 12/11/2020
• Initial Report FDA Received Date: 12/07/2020
• Supplement Report FDA Received Date: 12/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1