MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD DYNDTC5081B - 8"IV EXT SET NDLE FREE V SLIDE CLMP M/LU; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	DYNDTC5081B
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd dyndtc5081b - 8"iv ext set ndle free v slide clmp m/lu had flow issues it was reported by the customer that concern w/power injection.Issue occurred with a stoke patient involved and set is not power injection rated and caused an extravasation on this stroke patient.I am not going to pretend what that means.But we have pulled all of these off the shelf and now have the b braun product in." verbatim: rcc received a complaint via email.Email(s) attached.Concern w/power injection.Issue occurred with a stoke patient involved and set is not power injection rated and caused an extravasation on this stroke patient.I am not going to pretend what that means.But we have pulled all of these off the shelf and now have the b braun product in.".
Additional Manufacturer Narrative
It was reported by the customer that concern w/power injection.Issue occurred with a stoke patient involved and set is not power injection rated and caused an extravasation on this stroke patient.Eight samples of extension set dyndtc5081b was submitted for quality evaluation.The extension sets were visually inspected and no damages or abnormalities were identified.The extension sets were then connected to a sample infusion set and primed using water.A simulated infusion was conducted at a rate of 125 ml/hr for 1 hour.There were no signs of leakage, air-in-line or occlusions for any of the samples submitted.Additionally, the volume dispensed was collected into a graduated cylinder to verify the volume dispensed.The amount of fluid dispensed was accurate.Due to the reported failure not being replicated, a root cause could not be determined.Manufacturing has been made aware of the issue and we will continue to monitor this issue to determine if future action is needed.A device history record review for model dyndtc5081b lot number 23085292 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 09aug2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.
Event or Problem Description
No additional information was provided.

• Brand Name: BD DYNDTC5081B - 8"IV EXT SET NDLE FREE V SLIDE CLMP M/LU
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19424643
• Report Number: 9616066-2024-00813
• Device Sequence Number: 7947111
• Product Code: FPA
• UDI-Device Identifier: 40888277114839
• UDI-Public: (01)40888277114839
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2024

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 Expiration Date: 08/09/2026
• Device Catalogue Number: DYNDTC5081B
• Device Lot Number: 23085292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2024
• Supplement Date Received by Manufacturer: 08/28/2024
• Initial Report FDA Received Date: 05/30/2024
• Supplement Report FDA Received Date: 09/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown