MAUDE Adverse Event Report: BD CARIBE LTD. NEEDLE SPINAL S/SU 25GA 3-1/2IN QUINCKE; ANESTHESIA CONDUCTION NEEDLE

Catalog Number	405180
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).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 a needle spinal s/su 25ga 3-1/2in quincke had leakage.The following was reported, "at the time of administering intrathecal oncological medication, the syringe does not tie with the spinal needle hub so the medication leaks, also in the puncture is very soft.".
Event or Problem Description
It was reported that a needle spinal s/su 25ga 3-1/2in quincke had leakage.The following was reported, "at the time of administering intrathecal oncological medication, the syringe does not tie with the spinal needle hub so the medication leaks, also in the puncture is very soft.".
Additional Manufacturer Narrative
H.6.Investigation: bd has not been provided with photos or samples for catalog 405180, lot 8123881 to investigate for this record.Unfortunately, as a result, bd was unable to verify the reported issues.Bd needles go through multiple inspections to comply with standards and as part of acceptance criteria disposition.No issues or discrepancies were reported for the reported batch and leak tests were performed with successful results.In regards to the needle flexibility condition, needles used for the complaint lot were reviewed and a complete inspection for the cannula were approved on jan 2018.

• Brand Name: NEEDLE SPINAL S/SU 25GA 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: 8457994
• Report Number: 2618282-2019-00153
• Device Sequence Number: 344572
• Product Code: BSP
• UDI-Device Identifier: 30382904051809
• UDI-Public: 30382904051809
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 04/17/2019

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 Expiration Date: 05/31/2023
• Device Catalogue Number: 405180
• Device Lot Number: 8123881
• Initial Date Received by Manufacturer: 03/12/2019
• Supplement Date Received by Manufacturer: 03/12/2019
• Initial Report FDA Received Date: 03/27/2019
• Supplement Report FDA Received Date: 04/17/2019
• 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