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

Model Number	30914
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The date received by manufacturer has been used for this field.Investigation summary: a complaint of product breaking was received from the customer.One unused sample was returned for investigation.Through visual inspection, separation was confirmed.The female luer had separated from the top of the set.Some solvent was seen on the tubing.No damage was noticed to the tubing.A device history record review could not be performed on model 30914 because the lot number is unknown.The manufacturing plant was notified of this defect.The root cause was incorrect insertion of tubing into component.Because this process is performed without a fixture, variations can occur in the execution of the operation.Preventative inspections are in place to ensure operators are performing the operation as stated in the sws.Visual inspection and testing is performed by quality inspectors during manufacturing.This incident has been added to our database of reported incidents.
Event or Problem Description
It was reported that the bd extension set microbore experienced damage product.The following information was provided by the initial reporter: broken at utilization.One of the connector tips / area frayed.

• Brand Name: BD EXTENSION SET MICROBORE
• Common Device Name: 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: 15136384
• Report Number: 9616066-2022-01020
• Device Sequence Number: 5197477
• Product Code: FPA
• UDI-Device Identifier: 50885403233317
• UDI-Public: 50885403233317
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/30/2022

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
• Operator of Device: Other
• Device Model Number: 30914
• Device Catalogue Number: 30914
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2022
• Initial Report FDA Received Date: 07/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown