MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD® QUINCKE SPINAL NEEDLE 27GA 3.50 IN; ANESTHESIA CONDUCTION NEEDLE

Catalog Number 405259

Device Problem Difficult to Open or Remove Packaging Material (2922)

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

Event Date 06/20/2022

Event Type  malfunction  

Manufacturer Narrative

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 bd® quincke spinal needle 27ga 3.50 in had poor perforation on the packaging.The following information was provided by the initial reporter: "problem of opening the medical device: packaging glued on all sides, absence of "easy" opening to maintain good sterility practices.Current state of the patient: impossible to open the device in optimal conditions of use, risk of desterilizing the medical device since the packaging must be torn to be able to take out the needle.Actions taken in the health care institution for the management of the patient: nr.¿.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval: yes.D10: returned to manufacturer on: 24oct2022.H6: investigation summary: one box with fifteen units were provided to our quality team for investigation.After visual inspection, it was observed that the peel tab of the package was sealed, preventing proper opening of the package.A device history review was performed for reported lot 2203003, finding a mechanical intervention related to the transversal blade and cutting valve.An incident was detected due to an error in the packaging machine causing the cross cutting blades to move and cut in the incorrect location, resulting in the peel tab remaining sealed as seen in the products returned.After a mechanical intervention is completed, inspections are performed before the equipment can restart.All records established the inspections were completed appropriately.Packaging parameters are set and validated according to procedure.Product undergoes testing and inspections throughout manufacturing, all results were reviewed for lot 2203003 and verified machine and packaging parameters were within required limits.Based on our investigation, this incident was determined to be related to issue with the cutters that occurred during manufacturing and the machine operator not properly discarding the impacted products.Manufacturing personnel have been notified of this incident to increase awareness.Complaints received on this device and the reported condition will continue to be tracked and trended for future occurrences.

Event Description

It was reported bd® quincke spinal needle 27ga 3.50 in had poor perforation on the packaging.The following information was provided by the initial reporter: "problem of opening the medical device: packaging glued on all sides, absence of "easy" opening to maintain good sterility practices.Current state of the patient: impossible to open the device in optimal conditions of use, risk of desterilizing the medical device since the packaging must be torn to be able to take out the needle.Actions taken in the health care institution for the management of the patient: nr¿.

• Brand Name: BD® QUINCKE SPINAL NEEDLE 27GA 3.50 IN
• 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: 15195968
• MDR Text Key: 305249875
• Report Number: 3003152976-2022-00362
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 11/30/2022

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 Catalogue Number: 405259
• Device Lot Number: 2203003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/11/2022
• Initial Date FDA Received: 08/09/2022
• Supplement Dates Manufacturer Received: 11/30/2022
• Supplement Dates FDA Received: 12/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1