MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 4 IN MINIBORE SET W/ T-CONNECTOR & INJ; INTRAVASCULAR ADMINISTRATION SET

Model Number	ME1046
Medical Device Problem Codes	Difficult to Remove (1528); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 20087364.Medical device expiration date: 2025-08-28.Device manufacture date: 2020-08-28.Medical device lot #: unknown.Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that 1 4 in minibore set w/ t-connector & inj set from lot 20087364, 1 set from an unspecified lot were difficult to disconnect from the iv tubing.The following information was provided by the initial reporter: we are back to the old t-tubes again on the pixs.#870254.These were the ones that we had problems getting them disconnected from the iv tubing and we got our old ones back and we did not have problems.Uses a bd t-connector extension set me1046 in our nicu, and we have been having a real struggle with the product not disconnecting easily from iv tubing.
Event or Problem Description
It was reported that 1 4 in minibore set w/ t-connector & inj set from lot 20087364, 1 set from an unspecified lot were difficult to disconnect from the iv tubing.The following information was provided by the initial reporter: "we are back to the old t-tubes again on the pixs.#870254.These were the ones that we had problems getting them disconnected from the iv tubing and we got our old ones back and we did not have problems." "uses a bd t-connector extension set me1046 in our nicu, and we have been having a real struggle with the product not disconnecting easily from iv tubing.".
Additional Manufacturer Narrative
H6: investigation summary a complaint of extension sets having issues disconnecting from primary tubing was received from the customer.Three unused samples were returned for investigation.No defects or damages were noticed during visual inspection.The sets were then connected and disconnected from a primary set.The sets were all disconnected with no issue.The extension sets were then primed and infused with the primary set.No issues were observed during the process.When the sets were disconnected post infusion no issues were observed.A device history record review for model me1046 lot number 20087364 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 28aug2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A root cause could not be determined as the failure could not be replicated.

• Brand Name: 4 IN MINIBORE SET W/ T-CONNECTOR & INJ
• 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
• MDR Report Key: 11646034
• Report Number: 9616066-2021-50683
• Device Sequence Number: 3049851
• Product Code: FPA
• UDI-Device Identifier: 50885403235984
• UDI-Public: 50885403235984
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2021

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: ME1046
• Device Catalogue Number: ME1046
• Device Lot Number: SEE SECTION H.10.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2021
• Initial Date Received by Manufacturer: 03/12/2021
• Supplement Date Received by Manufacturer: 04/13/2021
• Initial Report FDA Received Date: 04/09/2021
• Supplement Report FDA Received Date: 04/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1