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

Catalog Number 400273

Device Problem Obstruction of Flow (2423)

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

Event Date 12/28/2022

Event Type  malfunction  

Event 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).

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 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).

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
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16161183
• MDR Text Key: 307609544
• Report Number: 2618282-2023-00003
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00382904002732
• UDI-Public: (01)00382904002732
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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
• Report Date: 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 400273
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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