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

Catalog Number	260680
Medical Device Problem Codes	False Positive Result (1227); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using bd gaspak¿ ez campy container system sachets, a false positive result was obtained on unspecified number of patients.There was no health impact or consequence reported.
Additional Manufacturer Narrative
D4.Medical device expiration date: unknown.H4.Device manufacture date: unknown.D4.Medical device lot#: unknown.E1.Address information was not able to be obtained; therefore, md was used as a place holder.Investigation summary: a complaint investigation was performed, due to campy issue showing false positive with gaspak ez campy container catalog 260680.The investigation required to test product for functionality (microbiological performance, gas concentration test, condensate time), visual inspection, incoming and batch record review.Retention samples unable to be tested.Batch number was not received.Returned goods not received for investigation.Incoming and batch record review unable to be performed since batch number was not provided by customer.From a period of 1 year (apr2025 to 29apr2026) quality notification (qn) system was evaluated.No qns were issued due to product performance failure.A complaint history review was conducted.No trend was found relating to the claim reported.Complaint is not confirmed.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.

• Brand Name: BD GASPAK¿ EZ CAMPY CONTAINER SYSTEM SACHETS
• 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: 25071616
• Report Number: 2647876-2026-00048
• Device Sequence Number: 16058572
• Product Code: KZJ
• UDI-Device Identifier: 30382902606803
• UDI-Public: (01)30382902606803
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 04/29/2026

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: 260680
• Device Lot Number: UNKNOWN
• 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: 04/09/2026
• Initial Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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