MAUDE Adverse Event Report: BD CARIBE LTD. BD PERISAFE¿ KITS; ANESTHESIA CONDUCTION KIT

Model Number	400273
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter phone #: (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that 2 bd perisafe¿ kits experienced device damage while still considered operable.The following information was provided by the initial reporter: filter is missing in bd perisafe kit ( 2 units).
Event or Problem Description
It was reported that 2 bd perisafe¿ kits experienced device damage while still considered operable.The following information was provided by the initial reporter: filter is missing in bd perisafe kit (b)(4) units).
Additional Manufacturer Narrative
H6: investigation summary: based on the sample provided to bd for evaluation, the reported condition was verified.The manufacturing facility has been notified of this incident and no discrepancy or non-conformance were identified that could have contributed to the reported condition.A review of the device history record was performed, and no quality issues were found during production.The most probably root cause has been identified as operator error during the manual assembly of the tray.H3 other text : see h10.
Event or Problem Description
It was reported that 2 bd perisafe¿ kits experienced device damage while still considered operable.The following information was provided by the initial reporter: filter is missing in bd perisafe kit ( 2 units).
Additional Manufacturer Narrative
After additional review, the reported event has been determined to be a case of tray missing component, which is unlikely to cause harm/serious injury.It has therefore been determined that this event does not require mdr submission/reporting.The initial mdr submission, (mfr report# 2618282-2021-00060), and the supplemental mdr, (mfr report # 2618282-2021-00060), may be disregarded.

• Brand Name: BD PERISAFE¿ KITS
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• Manufacturer (Section G): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12675867
• Report Number: 2618282-2021-00060
• Device Sequence Number: 11894657
• Product Code: CAZ
• UDI-Device Identifier: 30382904002733
• UDI-Public: 30382904002733
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K953790
• 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,Followup,Followup
• Report Date (Section B): 04/13/2022

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: 09/30/2025
• Device Model Number: 400273
• Device Catalogue Number: 400273
• Device Lot Number: 0281597
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2021
• Supplement Date Received by Manufacturer: 10/28/2021; 04/13/2022
• Initial Report FDA Received Date: 10/21/2021
• Supplement Report FDA Received Date: 11/17/2021; 04/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2020
• 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