MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. ASSEMBLY NAC-Y SITE (0.088 TUBING) OEM; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 8100-027

Device Problem Device Markings/Labelling Problem (2911)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/20/2021

Event Type  malfunction  

Manufacturer Narrative

"date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).

Event Description

It was reported that 1500 assembly nac-y site (0.088 tubing) oem had a mix of product types in a pack before use.The following was reported by the initial reporter: "mixed product.Customer was sent this lot 2 x's: (b)(4) pcs in oct 2020 ; (b)(4) pcs in dec 2020.".

Manufacturer Narrative

H6: investigation summary a 8100-027 sample was not required for investigation of this feedback as the customer provided photographs of the affected samples; analysis of the photographs confirmed the customer's experience with two different types of component identified within the bulk packaging.The details of this feedback were forwarded to the manufacturing site for investigation.They confirmed that it is possible that the mixed product occurred due to incorrect segregation of the two components following the assembly process; the segregation process is a manual procedure and is likely to have occurred due to human error.A review of the production records for lot 20108173 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.A review of the customer feedback database indicates that this is an isolated feedback with no further reports of this nature against the 8100-027 product in the past 12 months.

Event Description

It was reported that 1500 assembly nac-y site (0.088 tubing) oem had a mix of product types in a pack before use.The following was reported by the initial reporter: "mixed product - per the attached.Customer was sent this lot 2 x's: 60k pcs in oct 2020 ; 30k pcs in dec 2020.".

• Brand Name: ASSEMBLY NAC-Y SITE (0.088 TUBING) OEM
• 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 22244 ; MX 22244
• MDR Report Key: 11325375
• MDR Text Key: 249051268
• Report Number: 9616066-2021-50228
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 03/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 8100-027
• Device Lot Number: 20108173
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1