MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD GASPAK¿ CO2 INDICATORS; DEVICE, GAS GENERATING

Model Number	271055
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: this memo serves to summarize findings on recent complaint on product 271055, lot number b01d260m where it was reported the product label has an expiration of 08-31-2024 and a certificate of 08-28-2024.The label was confirmed to be correct per the batch history record; therefore the certificate was updated with the correct expiration date of 08-31-2024.The matter was investigated, and a quality notification was initiated.Based upon this information, the complaint is confirmed.A review of past complaints on this product over the past 12 months yielded no trend seen for this issue as of (b)(6) 2021.However, bd will continue to monitor for complaint trending.The review of the device history record was completed with no issue being noted.
Event or Problem Description
It was reported that while using bd gaspak¿ co2 indicators incorrect label information was observed by the laboratory personnel.There was no report of patient impact.The following information was provided by the initial reporter: "expiry on product does not match certificate.".

• Brand Name: BD GASPAK¿ CO2 INDICATORS
• Common Device Name: DEVICE, GAS GENERATING
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12978267
• Report Number: 1119779-2021-01945
• Device Sequence Number: 4569063
• Product Code: KZJ
• UDI-Device Identifier: 30382902710555
• UDI-Public: 30382902710555
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/23/2021

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: 08/28/2024
• Device Model Number: 271055
• Device Catalogue Number: 271055
• Device Lot Number: B01D260M
• 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: 11/15/2021
• Initial Report FDA Received Date: 12/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2021
• 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