MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD SPINAL¿ NEEDLE; SPINAL NEEDLE

Catalog Number 405259

Device Problem Leak/Splash (1354)

Patient Problem Injury (2348)

Event Date 10/10/2019

Event Type  Injury  

Manufacturer Narrative

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 that during use bd spinal¿ needle the joint was deformed at the tip where the syringe is threaded which causes loss at the time of inoculation.The following information was provided by the initial reporter, translated from spanish to english: the product is defective in a lot that will identify why the device's joint is deformed, in the report related to reference 405259 with lot 1804015.It was used in a (b)(6) year-old patient in the service and was classified as a non-serious adverse event in the internal report they made on (b)(6) 2019 and which was detailed in the procedure at the time of using the device as it presented deformity at the tip where the syringe is threaded which causes loss at the time of inoculation and leads to injury to the patient.

Event Description

It was reported that during use bd spinal¿ needle the joint was deformed at the tip where the syringe is threaded which causes loss at the time of inoculation.The following information was provided by the initial reporter, translated from spanish to english: the product is defective in a lot that will identify why the device's joint is deformed, in the report related to reference (b)(4) with lot 1804015.It was used in a 24-year-old patient in the service and was classified as a non- serious adverse event in the internal report they made on (b)(6) 2019 and which was detailed in the procedure at the time of using the device as it presented deformity at the tip where the syringe is threaded which causes loss at the time of inoculation and leads to injury to the patient.

Manufacturer Narrative

Correction: type of reportable events: serious injury.Investigation summary: no photos or physical samples that display the reported condition were available for investigation.A device history record review did not reveal any documented quality issues during the production of lot number 1804015 that could have contributed to this incident.Product is inspected throughout the manufacturing process to ensure the quality of the device.Based on the available information, we were not able to identify a root cause at this time.Examination of the product involved may provide clarification as to the cause for the reported failure.Complaints received for this device and reported issue will continue to be tracked and trended for future occurrence.

• Brand Name: BD SPINAL¿ NEEDLE
• Type of Device: SPINAL NEEDLE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 9290280
• MDR Text Key: 203897749
• Report Number: 3003152976-2019-00767
• Device Sequence Number: 1
• Product Code: BSP
• 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: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: 405259
• Device Lot Number: 1804015
• Date Manufacturer Received: 10/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 24 YR