MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD INFUSION DEVICE PRESSURE RESISTANT, LL; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 03500110109HN

Device Problem Component Missing (2306)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/20/2023

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone #: (b)(6).Medical device lot #: 220220611 was reported, however, this is not a lot # manufactured for the reported catalog #.Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that the bd infusion device pressure resistant, ll prime cap was missing.The following information was provided by the initial reporter: verbatim: prime cap was missing in the package.

Event Description

It was reported that the bd infusion device pressure resistant, ll prime cap was missing.The following information was provided by the initial reporter: prime cap was missing in the package.

Manufacturer Narrative

Investigation summary: a 03500110109hn product was not available for investigation, however the customer confirmed that the complaint sample was from lot: 20220611.The customer has indicated that a cap on the male luer was missing within the sealed packaging.As part of the investigation, the customer provided a photograph of the affected sample; analysis of the photograph confirmed that the male luer cap was missing (appendices 1 & 2).The details of this feedback were forwarded to the legal manufacturer, anhui tiankang medical products co.Ltd, for investigation.A review of the production records from lot: 20220611 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.They confirmed that this is a manual assembly step and therefore the customer's experience is likely to have occurred due to human error.In order to reduce the likelihood of operator error, the production personnel have been informed of this feedback to ensure that they are following the correct assembly process.

• Brand Name: BD INFUSION DEVICE PRESSURE RESISTANT, LL
• Type of Device: 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: 17299442
• MDR Text Key: 319062053
• Report Number: 9616066-2023-01403
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/24/2023

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
• Device Operator: Other
• Device Catalogue Number: 03500110109HN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/20/2023
• Initial Date FDA Received: 07/11/2023
• Supplement Dates Manufacturer Received: 07/24/2023
• Supplement Dates FDA Received: 08/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1