MAUDE Adverse Event Report: CAREFUSION, INC 17GX3.5 WEISS 19G OE 5ML LOR LS 10ML LS; EPIDURAL KIT

Catalog Number 400853

Device Problem Leak/Splash (1354)

Patient Problem Injury (2348)

Event Date 09/05/2019

Event Type  malfunction  

Manufacturer Narrative

Device expiration date: unknown.The customer's address is unknown: (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.

Event Description

It was reported that the 17gx3.5 weiss 19g oe 5ml lor ls 10ml ls experienced tip/luer of syringe breaking off during use.The following information was provided by the initial reporter: per customer email: user facility was trialing 400853 epidural tray¿ on friday 9/5 they had an incident where the glass syringe tip broke off in the epidural needle.When trying to retrieve it, dr.Cut his hand.He was given a new epidural tray and able to complete the procedure with some delay but he reported no harm to the patient.

Manufacturer Narrative

Investigation summary: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Bd was not able to duplicate or confirm the customer¿s indicated failure as no sample, batch, or lot code was provided.

Event Description

It was reported that the 17gx3.5 weiss 19g oe 5ml lor ls 10ml ls experienced tip/luer of syringe breaking off during use.The following information was provided by the initial reporter: per customer email: user facility was trialing 400853 epidural tray¿ on friday 9/5 they had an incident where the glass syringe tip broke off in the epidural needle.When trying to retrieve it, dr.Cut his hand.He was given a new epidural tray and able to complete the procedure with some delay but he reported no harm to the patient.

• Brand Name: 17GX3.5 WEISS 19G OE 5ML LOR LS 10ML LS
• Type of Device: EPIDURAL KIT
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• MDR Report Key: 9120391
• MDR Text Key: 217462840
• Report Number: 1625685-2019-00115
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 400853
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 09/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other