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 Complete Blockage (1094)

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

Event Date 08/04/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: medical device lot #: 21119904, medical device expiration date: 02-nov-2026, device manufacture date: 21-nov-2021.Medical device lot #: 21119906, medical device expiration date: 05-nov-2026, device manufacture date: 02-nov-2021.Medical device lot #: 22029682, medical device expiration date: 10-feb-2027, device manufacture date: 10-feb-2022.Medical device lot #: 22029709, medical device expiration date: 02-nov-2026, device manufacture date: 11-feb-2022.Medical device lot #: 22049055, medical device expiration date: 06-apr-2027, device manufacture date: 05-apr-2022.

Event Description

It was reported that the 9 bd extension set microbore slide clamp experienced flow issue blockage.The following information was provided by the initial reporter: when attempting to prime with a syringe/unable to prime.

Event Description

It was reported that the 9 bd extension set microbore slide clamp experienced flow issue blockage.The following information was provided by the initial reporter: when attempting to prime with a syringe/unable to prime.

Manufacturer Narrative

Investigation summary: two sets (model #me2020, lot #unknown) were received for investigation.It was reported by the customer that "when attempting to prime with a syringe/unable to prime".Fluid was attempted to be flushed through the sets with a bd 10 ml syringe.One set was able to be flushed without issue.One set appeared to have an occlusion at the top connector of the tubing.This set was examined under magnification where an occlusion can be observed.A quality notification has been sent to the manufacturer.The manufacturer was able to confirm the failure.The quality staff reviewed the production line where the effected model was operating.On different occasions, they observed pieces had accumulated in some operations while waiting for the flow test, which is used to ensure the flow of the set.The staff had a meeting to explain the importance of this operation that was being omitted.The root cause if the failure can be attributed to the lack of process in the production of the set.A quality notification was created to prevent this defect.A device history record review could not be performed on model me2020 because a lot number is unknown.

• 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: 15325511
• MDR Text Key: 305418096
• Report Number: 9616066-2022-01255
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 20885403236256
• UDI-Public: 20885403236256
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: ME2020
• Device Lot Number: 22049055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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