MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. BD GASPAK¿ EZ CO2 GAS GENERATING POUCH SYSTEM; DEVICE, GAS GENERATING

Catalog Number	260684
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: a complaint investigation was performed due to problem with generate co2 environment with gaspak ez co2 pouch catalog 260684, batch no.: 5303157 on retention samples and returned goods.The investigation required to perform functional test (microbiological performance, gas concentration test), visual inspection, incoming and batch record review.Functional test on retention samples and returned goods showed satisfactory results on microbiological performance and unsatisfactory results on gas concentration test.Low co2 level observed.No discrepancies observed during the visual inspection.Batch record review did not show any evidence of customer claim.Incoming record not available, lot received under skip lot program.A complaint history review was conducted.No trend was found relating to the incident lot number.However, a trend was identified due to customer claim.Complaint is confirmed.The supplier has initiated further root cause investigation relating to this situation through corrective and preventive actions process.Information will be captured on trend reports and monitored.
Event or Problem Description
It was reported that while using bd gaspak¿ ez co2 gas generating pouch system, the customer noticed the sachets are intermittently failing to generate the appropriate co2 environment on unspecified number of patient samples.However, when the customer tested a different lot from a sister hospital, the sachets worked as expected.There was no health impact or consequence reported.

• Brand Name: BD GASPAK¿ EZ CO2 GAS GENERATING POUCH SYSTEM
• Common Device Name: DEVICE, GAS GENERATING
• Manufacturer (Section D): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• Manufacturer (Section G): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• Manufacturer Contact: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 24910863
• Report Number: 2647876-2026-00026
• Device Sequence Number: 9928464
• Product Code: KZJ
• UDI-Device Identifier: 30382902606841
• UDI-Public: (01)30382902606841(17)270101(10)5303157
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/15/2026

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 Catalogue Number: 260684
• Device Lot Number: 5303157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2025
• 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