MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE SPINAL S/SU 20GA 6IN QUINCKE CE; NEEDLE, SPINAL, SHORT TERM

Catalog Number 400368

Device Problem Illegible Information (4050)

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

Event Date 02/01/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4): initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.H3 other text : see h10 manufacture narrative.

Event Description

We have bd canulas ref 400368 where the batch number is illegible on the packaging (see attachment).We cannot trace our dm properly.As we have not kept the box, we cannot use these canulas.The equivalent of a box is involved.Is it possible to send us compensation for the unusable canulas? picture available in attchment.

Manufacturer Narrative

Investigation summary: one photo was provided for investigation.It is observed a tyvek for catalog 400368 ¿ 20ga x 6¿ (the yellow square in the tyvek represents 20ga needles).The lot number, expiration date and the needle¿s measurements are illegible.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Based on the teams investigation, possible root cause is associated with g incorrect printer adjustment in the multivac machine during the flexographic printing.Manufacturing personnel have been notified of this incident to increase awareness of this matter.

Event Description

No additional information received.

• Brand Name: NEEDLE SPINAL S/SU 20GA 6IN QUINCKE CE
• Type of Device: NEEDLE, SPINAL, SHORT TERM
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MDS DCHU; 75 north fairway drive; vernon hills IL 60061
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18658459
• MDR Text Key: 334742812
• Report Number: 2618282-2024-00005
• Device Sequence Number: 1
• Product Code: MIA
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K210978
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 02/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 400368
• Device Lot Number: 3150814
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1