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

Catalog Number 20350E-0006

Device Problem Packaging Problem (3007)

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

Event Date 05/25/2022

Event Type  malfunction  

Event Description

It was reported that prior to using a bd smartsite¿ extension set, the product was damaged.The following information was provided by the initial reporter: the filters we receive when we order this item are often damaged.They are packed cramped, there is a kink on the hose so that it is damaged.

Manufacturer Narrative

Medical device lot #: 35900784.Medical device expiration date: unknown.Device manufacture date: unknown.Medical device lot #: 35900623.Medical device expiration date: unoknown.Device manufacture date: unknown.Initial reporter address 1: (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H.6 investigation summary: a 20350e-0006 product was not available for investigation; however the customer indicated the complaint sample was from lot 35900623 or 35900784.Unfortunately, the lot numbers provided are incorrect and not recognised in any manufacturing records for the 20350e-0006 product.The feedback provided by the customer indicates that they are frequently seeing kinked tubing, which results in occlusion alarms being experienced during infusion.As part of the investigation the customer provided a photograph of the affected sample; analysis of the photograph confirmed the customer's experience with a kink observed to the tubing at the upper filter joint.The details of this feedback were forwarded to the manufacturing site for further investigation.In this instance a lot number was not available and therefore it is not possible to perform a review of the production documentation for this particular product.The root cause of the customer¿s experience could not be determined in this instance; however previous reports of kinked tubing have been attributed to inadequate coiling of the set prior to packaging and sterilisation.This is a manual process, and it is likely to have occurred due to human error.Although a definitive root cause could not be determined in this instance, the quality team at the manufacturing site have been informed of this report and will continue to monitor the incoming feedback and remain vigilant to issues of this nature during future production.A review of the customer feedback database indicates that this is a rare occurrence with a small number of similar reports against the 20350e-0006 set in the past 12 months h3 other text : see h10.

Event Description

It was reported that prior to use the bd smartsite¿ extension set was packed cramped, and there is kinked on the hose so that it is damaged.The following information was provided by the initial reporter: the filters we receive when we order this item are often damaged.There is a kink on the hose so that it is damaged.This means that they do not work well, that the infusion pump reports high pressure.

• Brand Name: BD 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14853926
• MDR Text Key: 296794763
• Report Number: 9616066-2022-00780
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: NO
• 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: 07/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 20350E-0006
• Device Lot Number: SEE H.10.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2022
• 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