MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ASSEMBLY NAC Y-SITE (0.104 POCKET) OEM; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 8100-029

Device Problem Misassembled (1398)

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

Event Date 11/01/2022

Event Type  malfunction  

Event Description

It was reported that the bd assembly nac y-site (0.104 pocket) oem experienced mixed products.The following information was provided by the initial reporter, translated from chinese to english: "mixed product.".

Manufacturer Narrative

Initial reporter phone #: (b)(6).Medical device lot #: 22028855.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: due a previous complaint reported for mode 8100-032 by failure mode mixed products a gemba walk was carried out with the cmrb to verify the current controls and to identify the potential root cause regarding to the failure mode reported.The investigation was documented thorough the tj cc fi us pr (b)(4) mixed product dir (b)(4), it was determined as the most possible root cause: that personnel failed in the handle of material in packaging area by personnel during the packaging process due to not keep material identified adequately.And currently the failure mode is being attended through capa 5475276.Root cause definition through a previous investigation it was determinate as the most possible root cause that personnel failed in the handle of material in packaging area by personnel during the packaging process due to not keep material identified adequately.Corrective and preventive actions no additional preventive and corrective actions were required due to the failure mode is being attended through the capa 5475276 that is under implementation phase.

Event Description

It was reported that the bd assembly nac y-site (0.104 pocket) oem experienced mixed products.The following information was provided by the initial reporter, translated from chinese to english: mixed product.

• Brand Name: BD ASSEMBLY NAC Y-SITE (0.104 POCKET) 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
• 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: 15869104
• MDR Text Key: 304349205
• Report Number: 9616066-2022-01811
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 11/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 8100-029
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2022
• 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