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

Catalog Number	20511E
Medical Device Problem Codes	Leak/Splash (1354); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2023
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.
Event or Problem Description
It was reported that bd alaris smartsite combination extension set was damaged.The following information was received by the initial reporter with the verbatim: we received a bad lot of iv combination extension sets 20511e.The injection port is facing the wrong way.It¿s not every iv line in the lot but we have found several of them so far.The lot# is 23089344.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
The customer reported the injection port is facing the wrong way, and returned 1 sample of mat# 20511e and lot# 23089344.The set was visually examined for defects and abnormalities, and the defect of injection port facing the wrong way was verified.The male luer and female luer were switched orientations on the set.The failure of misassembly was verified by the manufacturing site, and the root cause was traced to assembly error.The personnel did not follow assembly instructions, and possibly misused orientation fixtures fx-1082/1083.A quality alert was issued to personnel regarding this failure on (b)(6) 2023.Device history record review for model 20511e lot number 23089344 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 24aug2023.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.

• Brand Name: BD ALARIS SMARTSITE COMBINATION 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18089359
• Report Number: 9616066-2023-02171
• Device Sequence Number: 12451160
• Product Code: FPA
• UDI-Device Identifier: 50885403234932
• UDI-Public: (01)50885403234932
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K931173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2024

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: Other
• Device Expiration Date: 08/24/2026
• Device Catalogue Number: 20511E
• Device Lot Number: 23089344
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2023
• Supplement Date Received by Manufacturer: 01/03/2024
• Initial Report FDA Received Date: 11/07/2023
• Supplement Report FDA Received Date: 01/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown