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

Catalog Number	CM42500E-07
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd alaris smartsite gravity set experienced component separation.The following information was provided by the initial reporter: info captured from pr#7548204 entry description.It was reported by customer that over the weekend, one of our nurses opened a gravity set and the spike filter component was not attached to the tubing.No patient harm and did not delay the procedure (except to go get second set).Verbatim: hello, over the weekend, one of our nurses opened a gravity set and the spike filter component was not attached to the tubing.No patient harm did not delay procedure (except to go get second set) ref # (b)(4).Lot #2209417.Exp 10-25-2023.Additional info received on 05-apr-2023 are you able to advise occurrence date? 03-29 & 30-2023 any damaged observed on gravity sets or packaging? no are you able to return faulty gravity sets back to bd for investigation? if no, can a photo be provided? yes.Clarification of event date received on (b)(6) 2023.Additional record (b)(4) opened on (b)(6) 2023 to capture incident occurred on (b)(4) 2023.(b)(4) already opened on(b)(6) 2023 to captured incident occurred on(b)(6) 2023 (b)(4) incident date remained unknown as per customer response.We have had 3 complaints.All different dates and unrelated.These dates are correct.
Additional Manufacturer Narrative
H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.D.4 device expiration date: unknown.H.4 device manufacture date: unknown.
Event or Problem Description
It was reported that the bd alaris smartsite gravity set experienced component separation.The following information was provided by the initial reporter: info captured from pr#7548204 entry description.It was reported by customer that over the weekend, one of our nurses opened a gravity set and the spike filter component was not attached to the tubing.No patient harm and did not delay the procedure (except to go get second set).Verbatim: hello, over the weekend, one of our nurses opened a gravity set and the spike filter component was not attached to the tubing.No patient harm.Did not delay procedure (except to go get second set).Ref # cm42500e-07.Lot #2209417.Exp 10-25-2023.Additional info received on 05-apr-2023.Are you able to advise occurrence date? 03-29 & 30-2023.Any damaged observed on gravity sets or packaging? no.Are you able to return faulty gravity sets back to bd for investigation? if no, can a photo be provided? yes.Clarification of event date received on 08-apr-2023.Additional record pr#(b)(4) opened on 13-apr-2023 to capture incident occurred on (b)(6) 2023.Pr#(b)(4) already opened on 29-mar-2023 to captured incident occurred on (b)(4) 2023.Pr#(b)(4) incident date remained unknown as per customer response.We have had 3 complaints.All different dates and unrelated.These dates are correct.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 19-apr-2023.D4: medical device lot #: 22109417.D4: medical device expiration date: 25oct2025.H4: device manufacture date: 25oct2022.H6: investigation summary.The three samples were received and tested by our quality team with the customer's complaint of separation.The drip chambers were received detached from the tubing which verified the complaint immediately.The sets were analyzed under microscope and the separated end lacked solvent (or glue).This is the root cause- lack of solvent applied during assembly.The manufacturer has been notified and has made changes to production to eliminate further occurrences of this failure.The samples that presented with separation issues were all part of lot# 22109417 a device history record review for model cm42500e-07 lot number 22109417 was performed.There were no quality notifications issued for the failure mode reported by the customer during the build of this set.H3 other text : see h10.

• Brand Name: BD ALARIS SMARTSITE GRAVITY SET
• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16845944
• Report Number: 9616066-2023-00793
• Device Sequence Number: 20719742
• Product Code: FPA
• UDI-Device Identifier: 10885403473746
• UDI-Public: (01)10885403473746
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K931173
• 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): 05/24/2023

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 Expiration Date: 10/25/2025
• Device Catalogue Number: CM42500E-07
• Device Lot Number: 2209417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2023
• Supplement Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 05/01/2023
• Supplement Report FDA Received Date: 06/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2022
• 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