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

Model Number 400273

Device Problem Component Missing (2306)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/24/2021

Event Type  malfunction  

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 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 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).

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 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).

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
• Type of Device: 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
• MDR Text Key: 278118006
• Report Number: 2618282-2021-00060
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 30382904002733
• UDI-Public: 30382904002733
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K953790
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• 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
• Date Manufacturer Received: 04/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1