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

Catalog Number 405075

Device Problems Misconnection (1399); Defective Device (2588)

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

Event Date 07/01/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that there was a lack of stable connection between the bd univia¿ whitacre spinal needle and the guide, making it difficult to maintain both during use without displacement during the anesthetic administration into the subarachnoid space.Additionally, it was reported that the needle was noticed to be deformed during use while inserting it.The following information was provided by the initial reporter, translated from polish to english: "the lack of a stable connection between the needle and the guide making it impossible to maintain the needles and guide without displacement during administration of the anesthetic agent into the subarachnoid space.The material used in the needle holder makes it difficult to identify the presence of cerebrospinal fluid in the needle / lack of proper translucency the needle is permanently deformed during insertion the guide is too short, which makes it difficult to insert the needle into the subarachnoid space correctly.".

Manufacturer Narrative

H.6.Investigation summary: six samples in their original sealed package were returned to our quality engineer for investigation.The product was visually inspected and no defects were identified.The length of the cannula from the introducer and the needle length were measured and found to be within specification.A device history was performed and found no non-conformances related to the reported issue during production of batch: 1807023.Product undergoes a series of testing and inspections throughout the manufacturing process to ensure the quality and functionality of the device.All lot release testing was reviewed and found product met requirements, no issues were identified.Based on the available information we cannot determined a root cause related to our manufacturing process at this time.Complaints for this device and defect will continue to be monitored by our quality team for signs of emerging trends.H3 other text : see section h.10.

Event Description

It was reported that there was a lack of stable connection between the bd univia¿ whitacre spinal needle and the guide, making it difficult to maintain both during use without displacement during the anesthetic administration into the subarachnoid space.Additionally, it was reported that the needle was noticed to be deformed during use while inserting it.The following information was provided by the initial reporter, translated from polish to english: "1.The lack of a stable connection between the needle and the guide making it impossible to maintain the needles and guide without displacement during administration of the anesthetic agent into the subarachnoid space.2.The material used in the needle holder makes it difficult to identify the presence of cerebrospinal fluid in the needle / lack of proper translucency.3.The needle is permanently deformed during insertion.4.The guide is too short, which makes it difficult to insert the needle into the subarachnoid space correctly.".

• Brand Name: BD UNIVIA¿ WHITACRE 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: 8794835
• MDR Text Key: 156756527
• Report Number: 3003152976-2019-00467
• 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,health professional,o
• Type of Report: Initial,Followup
• Report Date: 10/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: 405075
• Device Lot Number: 1807023
• Date Manufacturer Received: 07/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other