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

Catalog Number ME2020

Device Problem Fitting Problem (2183)

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

Event Date 10/05/2022

Event Type  malfunction  

Manufacturer Narrative

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 by the customer that the bd extension set microbore slide clamp was difficult to unscrew.The following information was provided by the initial reporter: the process is to lengthen the tubing so the patient can still have meds while in the scanner.The tubing is difficult to unscrew from each other when trying to remove it and return to normal length tubing.

Event Description

It was reported by the customer that the bd extension set microbore slide clamp was difficult to unscrew.The following information was provided by the initial reporter: the process is to lengthen the tubing so the patient can still have meds while in the scanner.The tubing is difficult to unscrew from each other when trying to remove it and return to normal length tubing.

Manufacturer Narrative

H6: investigation summary no product or photo was returned by the customer.The customer complaint of adapter / connector defective / damaged could not be verified due to the product not being returned for failure investigation.A device history record review for model me2020 lot number 22079491 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 28jul2022.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.

• Brand Name: BD EXTENSION SET MICROBORE SLIDE CLAMP
• 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: 15736365
• MDR Text Key: 307506690
• Report Number: 9616066-2022-01680
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403236259
• UDI-Public: 10885403236259
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ME2020
• Device Lot Number: 22079491
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2022
• 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