MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS VERSASAFE EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	10796814
Medical Device Problem Codes	Leak/Splash (1354); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.D.4 device expiration date: unknown.H.4 device manufacture date: unknown.
Event or Problem Description
It was reported that the bd alaris versasafe extension set experienced disconnection and leaked.This is 2 of 2 related events.The following information was provided by the initial reporter: posted by user, intake on (b)(6) 2023 12:48:21 am intake note after inserting a piv and flushing through the slip-tip t-connector, it was attached and secured with additional tape at the connection.Approx 5 mins later, blood was noted on the armboard.Upon further assessment, it was determined that the t-connector had migrated out slightly and blood was backflowing out of the catheter.The t-connector was tightened and flushed, however while retaping, it could be seen floating back out of the catheter.At this time, the nnp was at bedside and asked this rn to utilize our regular screw on type of t-connector.The t-connector was changed out and the piv retaped with no further issues of blood leaking out.Had i not been at bedside when this happened, the infant could have lost a lot of blood during the time that would pass before my next piv check 55 mins later.It is a safety issue.
Event or Problem Description
It was reported that the bd alaris versasafe extension set experienced disconnection and leaked.This is 2 of 2 related events.The following information was provided by the initial reporter: posted by user, intake on 4/12/2023 12:48:21 am intake note after inserting a piv and flushing through the slip-tip t-connector, it was attached and secured with additional tape at the connection.Approx 5 mins later, blood was noted on the armboard.Upon further assessment, it was determined that the t-connector had migrated out slightly and blood was backflowing out of the catheter.The t-connector was tightened and flushed, however while retaping, it could be seen floating back out of the catheter.At this time, the nnp was at bedside and asked this rn to utilize our regular screw on type of t-connector.The t-connector was changed out and the piv retaped with no further issues of blood leaking out.Had i not been at bedside when this happened, the infant could have lost a lot of blood during the time that would pass before my next piv check 55 mins later.It is a safety issue.
Additional Manufacturer Narrative
H6: investigation summary no product or photo was returned by the customer.The customer complaint of separation and backflow could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on material 10796814 because the lot number is unknown.The root cause of this failure could not be identified without a failure investigation.

• Brand Name: BD ALARIS VERSASAFE EXTENSION 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
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16882186
• Report Number: 9616066-2023-00835
• Device Sequence Number: 7461149
• Product Code: FPA
• UDI-Device Identifier: 10885403234330
• UDI-Public: (01)10885403234330
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• 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): 05/18/2023

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: Health Professional
• Device Catalogue Number: 10796814
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2023
• Supplement Date Received by Manufacturer: 05/18/2023
• Initial Report FDA Received Date: 05/05/2023
• Supplement Report FDA Received Date: 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown