MAUDE Adverse Event Report: BD CARIBE LTD. NEEDLE SPINAL S/SU 22GA 3-1/2IN QUINCKE; ANESTHESIA CONDUCTION NEEDLE

Catalog Number	405181
Medical Device Problem Codes	Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device expiration date: unknown.Device manufacture date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that defected catheter was found before use with a needle spinal s/su 22ga 3-1/2 in quincke.The following information was provided by the initial reporter, "stylet was longer than the needle.".
Event or Problem Description
It was reported that defected catheter was found before use with a needle spinal s/su 22ga 3-1/2in quincke.The following information was provided by the initial reporter, "stylet was longer than the needle.".
Additional Manufacturer Narrative
Investigation: bd has been provided with a sample for catalog 405181 lot 8305709 to investigate for this record.The sample was received open from the sealed blister and included all assembly components, such as a blister package, needle/stylet and shield.The needle/stylet has an excessive stylet protrude.As a result, bd was able to verify the reported issue.At investigation, the condition was related to a mechanical failure regarding the platina, in which it allows movement of cannula/stylet during the molding process.A corrective action regarding the platina was completed on february 2019.Dhr was performed and review of instrument calibration documented on the in process and final quality records were found within their calibration due date.

• Brand Name: NEEDLE SPINAL S/SU 22GA 3-1/2IN QUINCKE
• Common Device Name: ANESTHESIA CONDUCTION NEEDLE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• MDR Report Key: 8781044
• Report Number: 2618282-2019-00222
• Device Sequence Number: 16653582
• Product Code: BSP
• UDI-Device Identifier: 30382904051816
• UDI-Public: 30382904051816
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 405181
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 06/20/2019
• Supplement Date Received by Manufacturer: 06/20/2019
• Initial Report FDA Received Date: 07/11/2019
• Supplement Report FDA Received Date: 08/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other