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	Backflow (1064); Complete Blockage (1094); Restricted Flow rate (1248)
Health Effect - Clinical Code	Vasculitis (2004)
Date of Event	11/11/2020
Type of Reportable Event	Serious Injury
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 is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
Event or Problem Description
It was reported that blood backflowed in the 6 inch hep lock ext set when engaging the clamp and removing the syringe, causing the tubing to become occluded.This reportedly caused "infiltrations (extravasations)", phlebitis, and pain from the patient.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "the bd smartsite extension set ref (b)(4) is an unacceptable substitution for our current smartsite extension ref (b)(4).The rigidity of the tubing puts undo torque on the insertion site if the tubing needs to be looped away from a place of flexion.This is also causing local phlebitis which is leading to more infiltrations.If a place of flexion is to be avoided finding a suitable vein to place the iv becomes limited.When flushing the iv, engaging the clamp, and removing the syringe, blood backs up into the tubing causing the site to become occluded.We are seeing more iv starts due to occlusions, infiltrations (extravasations), and pain voiced from the patient.".
Event or Problem Description
It was reported that blood backflowed in the 6 inch hep lock ext set when engaging the clamp and removing the syringe, causing the tubing to become occluded.This reportedly caused "infiltrations (extravasations)", phlebitis, and pain from the patient.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "the bd smartsite extension set ref (b)(4) is an unacceptable substitution for our current smartsite extension ref (b)(4).The rigidity of the tubing puts undo torque on the insertion site if the tubing needs to be looped away from a place of flexion.This is also causing local phlebitis which is leading to more inifiltrations.If a place of flexion is to be avoided finding a suitable vein to place the iv becomes limited.When flushing the iv, engaging the clamp, and removing the syringe, blood backs up into the tubing causing the site to become occluded.We are seeing more iv starts due to occlusions, infiltrations (extravasations), and pain voiced from the patient.".
Additional Manufacturer Narrative
Investigation summary: one sample was returned by the customer.It was reported that the rigidity of the tubing puts undo torque on the insertion site.It also causes blood to back up into the tubing causing the site to become occluded.The set was examined for defects and abnormalities.No defects or abnormalities were observed.The set was connected to a 10 ml bd syringe and attempted to be flushed with at least 10 ml of a blue dye/water mixture.The set was able to be flushed.The failure was unable to be replicated.A device history record review could not be performed on model 20035e because a lot number was not provided by the customer.A root cause was unable to be determined because the failure was unable to be replicated.

• 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: 10963798
• Report Number: 9616066-2020-20538
• Device Sequence Number: 2470030
• 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?: Yes
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Initial Date Received by Manufacturer: 11/11/2020
• 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
• Outcome Attributed to Adverse Event: Other