MAUDE Adverse Event Report: BD CARIBE LTD. BD PERISAFE¿ EPIDURAL MINI-KIT; ANESTHESIA CONDUCTION KIT

Catalog Number	400273
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd perisafe¿ epidural mini-kit there was a clog.There was no report of patient impact.The following information was provided by the initial reporter, translated from dutch to english: epidural pumps on verlos are going into alarm more frequently (due to obstruction).
Additional Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd perisafe¿ epidural mini-kit there was a clog.There was no report of patient impact.The following information was provided by the initial reporter, translated from dutch to english: epidural pumps on verlos are going into alarm more frequently (due to obstruction).
Additional Manufacturer Narrative
H6: investigation summary no samples or photos received for investigation.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.

• Brand Name: BD PERISAFE¿ EPIDURAL MINI-KIT
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16161183
• Report Number: 2618282-2023-00003
• Device Sequence Number: 7005390
• Product Code: CAZ
• UDI-Device Identifier: 00382904002732
• UDI-Public: (01)00382904002732
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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
• Report Date (Section B): 02/03/2023

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: 400273
• 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: 12/28/2022
• Supplement Date Received by Manufacturer: 02/03/2023
• Initial Report FDA Received Date: 01/13/2023
• Supplement Report FDA Received Date: 02/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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