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

Catalog Number 20039E

Device Problem Component Missing (2306)

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

Event Date 09/01/2023

Event Type  malfunction  

Event Description

It was reported that bd alaris smartsite extension set was missing its clamp.The following information was provided by the initial reporter, translated from chinese to english: the extension tube doesn't have a clamp.

Manufacturer Narrative

B3.The date received by manufacturer has been used for this field.D.4.Medical device expiration 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.H.4.Device manufacture date: unknown.

Event Description

It was reported that bd alaris smartsite extension set was missing its clamp.The following information was provided by the initial reporter, translated from chinese to english: the extension tube doesn't have a clamp.

Manufacturer Narrative

H.6.Investigation summary: a 20039e sample was not available for investigation; furthermore, the lot number reported of 22076142 is incorrect and not recognised in the manufacture of the 20039e product.The feedback provided by the customer suggests the device did not contain a slide clamp.The details of this feedback were forwarded to the manufacturing site for investigation.In this instance it is likely that the assembly step for attaching the slide clamp was missed, and was not detected during subsequent assembly steps.This is a manually performed assembly step and is likely to have occurred due to human error.The correct lot number was not available and therefore it is not possible to perform a review of the production documentation for this particular product.The quality team at the manufacturing site has been informed of this report in order to be aware of the reported feedback during future production of this product.A review of the customer feedback database indicates that this is an isolated occurrence with no further reports of this nature against the 20039e product over the past 12 months.

Manufacturer Narrative

One 20039e sample from lot 22075142 was received in opened packaging for investigation; residual fluid was detected in the device.The feedback provided by the customer suggests the device did not contain a slide clamp.A visual inspection of the returned sample confirmed the customer's experience, as the device did not contain a slide clamp.The details of this feedback were forwarded to the manufacturing site for investigation.In this instance it is likely that the assembly step for attaching the slide clamp was missed, and was not detected during subsequent assembly steps.This is a manually performed assembly step and is likely to have occurred due to human error.A review of the production records for lot 22075142 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.

Event Description

Additional information- sample received.The extension tube doesn't have a clamp.

• Brand Name: BD ALARIS SMARTSITE EXTENSION SET
• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17796056
• MDR Text Key: 324042357
• Report Number: 9616066-2023-01923
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 27613203013820
• UDI-Public: (01)27613203013820
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K960280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 20039E
• Device Lot Number: 22075142
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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