MAUDE Adverse Event Report: UNSPECIFIED BD¿ SPINAL NEEDLE; ANESTHESIA CONDUCTION NEEDLE

Catalog Number UNKNOWN

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 08/25/2021

Event Type  malfunction  

Manufacturer Narrative

Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.(b)(4).Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the unspecified bd¿ spinal needle label was missing the reference and lot numbers, and the expiration date.The following information was provided by the initial reporter, translated from (b)(6) to english: "we have received a material vigilance concerning a missing element mentioning the reference/lot number/expiry date of a box of 18g spinal needle.".

Manufacturer Narrative

Investigation summary: there was no sample available but 3 photos were provided to bd for evaluation.With the 3 photos, the reported issue was confirmed.A review of the device history record was performed and no quality issues were found during production.A probably root cause was determined to be a jam within the labelling machine.A review of instrument calibration documents was performed and the reported issue was shared with the production team.H3 other text : see h10.

Event Description

It was reported that the unspecified bd¿ spinal needle label was missing the reference and lot numbers, and the expiration date.The following information was provided by the initial reporter, translated from french to english: "we have received a material vigilance concerning a missing element mentioning the reference/lot number/expiry date of a box of 18g spinal needle.".

• Brand Name: UNSPECIFIED BD¿ SPINAL NEEDLE
• Type of Device: ANESTHESIA CONDUCTION NEEDLE
• MDR Report Key: 12513679
• MDR Text Key: 272725748
• Report Number: 2243072-2021-02364
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 10/06/2021

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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/26/2021
• Initial Date FDA Received: 09/22/2021
• Supplement Dates Manufacturer Received: 10/06/2021
• Supplement Dates FDA Received: 10/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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