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

Catalog Number	42290E
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd gravity infusion set there was component separation.There was no report of patient impact.The following information was provided by the initial reporter: this is from esc found.It was found in two parts in the packaging.Had a quick look could not see any more like this on the shelves.We have two lot numbers at the moment this batch expires 2025-08-11 one month earlier than the other batch.Product opened before using noticed that it was disconnected form the drip chamber.Set couldn't be used delay in medication administration due to faulty set.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Added lot number from investigation investigation result - one 42290e sample from lot 22089273 was received in opened packaging for investigation; no residual fluid was detected in the device.The feedback provided by the customer suggests the device had separated at the drip chamber base before use.A visual inspection of the returned sample confirms the customer's experience, as a the device was returned with the tubing separated from the drip chamber spigot; some residual solvent was present at the affected joint.The details of this feedback were forwarded to the manufacturing site for investigation.Following a review of the manufacturing process, their analysis confirmed that the separation is most likely to have been caused by human error during the manual assembly of the affected tubing joint.A review of the production records for lot 22089273 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.In order to reduce the likelihood of operator error, the production personnel have been informed of this feedback to ensure that they are following the correct assembly process.A review of the customer feedback database indicates that this is an isolated feedback with no further reports of this nature against the 42290e product over the past 12 months.

• Brand Name: BD GRAVITY INFUSION 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17484266
• Report Number: 9616066-2023-01693
• Device Sequence Number: 17959295
• Product Code: FPA
• UDI-Device Identifier: 37613203010949
• UDI-Public: (01)37613203010949
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K820278
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2023

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: 08/11/2025
• Device Catalogue Number: 42290E
• Device Lot Number: 22089273
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2023
• Supplement Date Received by Manufacturer: 11/27/2023
• Initial Report FDA Received Date: 08/08/2023
• Supplement Report FDA Received Date: 12/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown