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

Model Number 11448964

Device Problem Misassembled (1398)

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

Event Date 06/09/2022

Event Type  malfunction  

Event Description

It was reported that the bd secondary administration set experienced missing components.The following information was provided by the initial reporter: rn from medical oncology was priming a secondary line when she noted that there was no rollar clamp available on the iv tubing that she had just opened.

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

The following fields were corrected: d9: device available for eval: no.D9: returned to manufacturer on: na.H6: investigation summary.Two photos of the product packaging was submitted, however, no photo of the product or product failure was provided.No product was returned by the customer.The customer complaint of misassembly could not be verified due to the product not being returned for failure investigation.A device history record review for model 11448964 lot number 22029005 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on (b)(6) 2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.

Event Description

It was reported that the bd secondary administration set experienced missing components.The following information was provided by the initial reporter: rn from medical oncology was priming a secondary line when she noted that there was no rollar clamp available on the iv tubing that she had just opened.

• Brand Name: BD SECONDARY ADMINISTRATION 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: 15108706
• MDR Text Key: 304604496
• Report Number: 9616066-2022-00961
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403234741
• UDI-Public: 50885403234741
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K790582
• 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: 08/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 11448964
• Device Catalogue Number: 11448964
• Device Lot Number: 22029005
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 07/06/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2022
• 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