MAUDE Adverse Event Report: TRAY EPID CONT WE17G3.5 SWC X3796; ANESTHESIA CONDUCTION KIT

Model Number 406151

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/07/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.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.Device manufacture date: unknown.Oem manufacture: the manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.

Event Description

It was reported that the tray epid cont we17g3.5 swc x3796 experienced leakage during use.The following information was provided by the initial reporter: material no: 406151 batch no: unknown.I don't have a lot number ¿ they kept the top cover but the lot number is not on that.They said the epidural was leaking at the hte connection of the tube an connector.

Event Description

It was reported that the tray epid cont we17g3.5 swc x3796 experienced leakage during use.The following information was provided by the initial reporter: material no: 406151, batch no: unknown.I don't have a lot number ¿ they kept the top cover but the lot number is not on that.They said the epidural was leaking at the hte connection of the tube an connector.

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 5/28/2020.H.6.Investigation: a lot number was not provided and as a result a device history record review could not be performed.The sample evaluation was unable to confirm the reported failure mode.The sample was visually acceptable.The connectors are one-time use and the failure mode could not be replicated with a used connector.This investigation could not identify any manufacturing contributions for the reported issue.Based on the limited results of the complaint investigation, a probable root cause could not be identified and no contributions from the manufacturing/design process were identified.H3 other text : see h.10.

• Brand Name: TRAY EPID CONT WE17G3.5 SWC X3796
• Type of Device: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 10002594
• MDR Text Key: 189844587
• Report Number: 2243072-2020-00665
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00382904061517
• UDI-Public: 00382904061517
• Combination Product (y/n): N
• PMA/PMN Number: DISCRETION
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 406151
• Device Catalogue Number: 406151
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2020
• Initial Date Manufacturer Received: 04/07/2020
• Initial Date FDA Received: 04/27/2020
• Supplement Dates Manufacturer Received: 04/07/2020
• Supplement Dates FDA Received: 09/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Other