MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION ADPTR,TUBE SET TO BAG,STER; SYRINGE, PISTON

Catalog Number	H93884
Medical Device Problem Codes	Obstruction of Flow (2423); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that six (6) exactamix adapters had a small piece of plastic preventing fluid from flowing through; some of the adapters appeared to be partially blocked.This was observed during use of the devices with the repeater pump and tubing sets.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
The devices have been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
B5: additionally, when the user pressed pump on the repeater pump with the adapter attached, nothing came out.Once the adapter was removed, the repeater device pumped successfully.H4: the lot was manufactured between march 11, 2023 ¿ march 12, 2023.H10: six (6) devices were received for evaluation.An unaided eye visual inspection was performed which observed blocked and deformed areas inside the adaptor barrel fluid pathway in all samples.A magnified inspection was performed, and completely blocked areas inside the barrel of four (4) samples and partially blocked deformed areas of the remaining two (2) samples were observed.Functional testing using sterile water was performed, and liquid flow was completely restricted of the 4 samples and partially restricted liquid flow of the remaining two (2) samples were observed.The reported condition was verified as deformed adapters, not a contamination condition.The cause of the condition was related to the manufacturing process.In the event of a fully occluded adapter, there would be no patient harm because a patient bag would not be used until the setup is complete.The pharmacist would review and approve the final bag before release to the end user.This could present a delay in compounding; however, the pharmacy could manually prepare the patient¿s therapeutic product to mitigate the potential delay.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: ADPTR,TUBE SET TO BAG,STER
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): AVAILMED; c. industrial lt. 001 mz. 105; no 20905 int a, col cd ind.; tijuana, baja california 22444 ; MX 22444
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 17619353
• Report Number: 1416980-2023-04302
• Device Sequence Number: 6057559
• Product Code: FMF
• UDI-Device Identifier: 00085412476827
• UDI-Public: (01)00085412476827
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K872743
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2024

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: Health Professional
• Device Expiration Date: 02/28/2026
• Device Catalogue Number: H93884
• Device Lot Number: 60444769
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 02/14/2024
• Initial Report FDA Received Date: 08/24/2023
• Supplement Report FDA Received Date: 03/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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