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 04/27/2023

Event Type  malfunction  

Event Description

It was reported while using bd infusion device pressure resistant, ll the spike cap came off before use.There was no report of patient impact.The following information was provided by the initial reporter: cap comes off before the product is unpacked.

Manufacturer Narrative

B.3.Date of event is unknown; awareness date has been used for this field.D.4.Medical device lot #: 220220611 was reported, however, this is not a lot # manufactured for the reported catalog #.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

H6: investigation summary a 03500110109hn product was not available for investigation, however the customer indicates that the cap of the luer was found to have been disconnected within the packaging.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 220220611 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.A definitive root cause for the customer¿s experience could not be determined as the sample was not available for investigation; however as a result of previous similar feedback, the manufacturing site have retrained the manufacturing operators to ensure that sufficient force is applied during the manual assembly of this component, which should reduce the likelihood of reports of this nature in future.

Event Description

It was reported while using bd infusion device pressure resistant, ll the spike cap came off before use.There was no report of patient impact.The following information was provided by the initial reporter: cap comes off before the product is unpacked.

• 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 ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16959523
• MDR Text Key: 315549049
• Report Number: 9616066-2023-00962
• 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: 06/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2023
• 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
• Date Manufacturer Received: 06/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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