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 03/24/2022

Event Type  malfunction  

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 in opening the product sterile because the end intended to open the needle pack is stuck together.So the part where a single spinal needle pack should be torn open.".

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

The following fields were updated due to additional information: d9: device available for eval yes, d9: returned to manufacturer on: 25-apr-2022.H6: investigation summary: one photo and three unit packs have been provided to our quality team for investigation.After visual inspection of both the photographs and physical samples, 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 2201009, no deviations or non-conformances related to this issue were identified during the manufacturing process.Packaging parameters are set and validated according to procedure.Product undergoes testing and inspections throughout manufacturing, all results were reviewed for lot 2201009 and verified machine and packaging parameters were within required limits, and results of the of the peel tab inspection was acceptable.While we cannot identify a direct issue, this incident can occur 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.

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 in opening the product sterile because the end intended to open the needle pack is stuck together.So the part where a single spinal needle pack should be torn open.".

• 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: 14135427
• MDR Text Key: 289437030
• Report Number: 3003152976-2022-00147
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/02/2022

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: 2201009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/24/2022
• Initial Date FDA Received: 04/18/2022
• Supplement Dates Manufacturer Received: 05/02/2022
• Supplement Dates FDA Received: 05/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2022
• 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