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

Catalog Number 405259

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/28/2022

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.Date of birth: unknown.The patient¿s age was used to determine a placeholder date for this field.

Event Description

It was reported while using the bd¿ quincke spinal needle the spinal needle is not able to tie properly with the syringe, so there is evidence of dripping of the drug when infusing it.The following information was provided by the initial reporter, translated from spanish to english: patient to whom intrathecal chemotherapy is being administered and the spinal needle is not able to tie properly with the syringe, so there is evidence of dripping of the drug when infusing it.

Manufacturer Narrative

Investigation summary: no physical samples that displays the reported condition were provided to our quality team for investigation.A device history review was performed for lot 2111005, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Five retained samples of the same lot were used for additional evaluation.The product was visually inspected, no damage or cracks were observed on or near the luer connection.Functional testing was performed, connecting the needle to a syringe.Liquid was able to pass from the syringe through the needle and no leakage was observed.Product is visually and functionally tested throughout manufacturing according to procedure, verifying all critical dimensions are within specification.Testing results for lot 2111005 verified product met all required limits.Based on the available information we are not able to identify a root cause at this time.Complaints received for this device and reported condition will continue to be monitored by our quality team for signs of emerging trends.

Event Description

It was reported while using the bd¿ quincke spinal needle the spinal needle is not able to tie properly with the syringe, so there is evidence of dripping of the drug when infusing it.The following information was provided by the initial reporter, translated from spanish to english: patient to whom intrathecal chemotherapy is being administered and the spinal needle is not able to tie properly with the syringe, so there is evidence of dripping of the drug when infusing it.

• Brand Name: BD¿ QUINCKE SPINAL NEEDLE
• Type of Device: ANESTHESIA CONDUCTION NEEDLE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15182842
• MDR Text Key: 304887263
• Report Number: 3003152976-2022-00356
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 405259
• Device Lot Number: 2111005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2021
• 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 Age: 13 YR
• Patient Sex: Male