MAUDE Adverse Event Report: BD CARIBE LTD. NEEDLE SP S/SU 24GA TW 3-1/2IN WHITACRE; ANESTHESIA CONDUCTION NEEDLE

Model Number 405133

Device Problems Break (1069); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/16/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported needle sp s/su 24ga tw 3-1/2in whitacre spinal needle was not working properly.This occurred on 6 occasions.The following information was provided by the initial reporter: spinal needle not advancing through introducer.Spinal needle is becoming stuck part way down 20g introducer.Introducer is insitu in patient.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-01-11.H6: investigation summary: four samples were returned to our quality team for investigation, two closed containers of reference 405260 20ga1.25in lot 1902014 and two closed containers of reference 405133 24ga x3.50in lot 7163898.The product was visually inspected, no damage or defects were observed on any of the product.Functional evaluations were performed and verified the 24ga x3.50in gauge needle does not fit into the 20ga1.25in gauge introducer.Five retained samples were used for additional evaluation.In all cases, the spinal needle was properly advanced through the introducer and no friction was observed.A device history review was performed for reported lot, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Product is visually and functionally inspected throughout the manufacturing process according to procedure, verifying all critical dimensions are within specification and there is no damage or defects with the product.All records were reviewed and no issues were identified during inspections for the reported lot.According to product specifications, the needle gauge must be a 25g or smaller to be used with this product.Based on our investigation it was determined the incorrect gauge size was used, not allowing for proper advancement.

Event Description

It was reported needle sp s/su 24ga tw 3-1/2in whitacre spinal needle was not working properly.This occurred on 6 occasions.The following information was provided by the initial reporter: spinal needle not advancing through introducer.Spinal needle is becoming stuck part way down 20g introducer.Introducer is insitu in patient.

• Brand Name: NEEDLE SP S/SU 24GA TW 3-1/2IN WHITACRE
• Type of Device: ANESTHESIA CONDUCTION NEEDLE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• MDR Report Key: 11023477
• MDR Text Key: 228433996
• Report Number: 2618282-2020-00105
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 30382904051335
• UDI-Public: 30382904051335
• Combination Product (y/n): N
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/10/2021

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
• Device Operator: Other
• Device Expiration Date: 06/30/2022
• Device Model Number: 405133
• Device Catalogue Number: 405133
• Device Lot Number: 7163898
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2021
• Initial Date Manufacturer Received: 11/18/2020
• Initial Date FDA Received: 12/16/2020
• Supplement Dates Manufacturer Received: 02/02/2021
• Supplement Dates FDA Received: 02/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1