MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. LOW SORBING EXT SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number C20350

Device Problem Defective Device (2588)

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

Event Date 05/08/2023

Event Type  malfunction  

Manufacturer Narrative

D.4.Medical device lot #: lot was reported; however, this is not a lot # 220089276 manufactured for the reported catalog #.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that 3 of the low sorbing ext set tubing was kinked.The following information was provided by the initial reporter, translated from french to english: we have encountered a non-conformity on a micron filter ref c20350 of lot 220089276.It turns out that the product presents folds, [.] we have encountered this problem on 3 pieces.

Event Description

It was reported that 3 of the low sorbing ext set tubing was kinked.The following information was provided by the initial reporter, translated from french to english: we have encountered a non-conformity on a micron filter ref (b)(4) of lot 220089276.It turns out that the product presents folds, we have encountered this problem on (b)(4) pieces.

Manufacturer Narrative

The following fields were updated due to additional information: d4: medical device lot #: 21085640 d4: medical device expiration date: h4: device manufacture date: h6: investigation summary a c20350 sample was not available for investigation; however, the customer indicated the complaint samples were from lot 21085640.The feedback provided by the customer suggests three sets were kinked at various locations on the filter extension set.As part of the feedback the customer provided photographs.A visual inspection of the photographs confirms the customers experience as the sets were kinked at various locations on the extension set.The details of this feedback were forwarded to the manufacturing site for investigation.The most likely area for kinked tubing to occur is during the coiling process; this is a manual process performed immediately prior to packaging during which each model code is coiled following a defined procedure which is tailored to take into account the component configuration of the product.In this instance it is likely that the manufacturing operative did not coil the sets in accordance with the correct coiling procedure.A review of the production records for lot 21085640 did not identify any in-process testing failures or quality deviations which may have caused or contributed to a report of this nature.

• Brand Name: LOW SORBING EXT 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17056431
• MDR Text Key: 317641118
• Report Number: 9616066-2023-01073
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 08/16/2023

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 Expiration Date: 08/11/2021
• Device Catalogue Number: C20350
• Device Lot Number: 21085640
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2023
• Initial Date FDA Received: 06/02/2023
• Supplement Dates Manufacturer Received: 08/15/2023
• Supplement Dates FDA Received: 08/27/2023
• 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