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

Catalog Number	405180
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 8219864, medical device expiration date: 2023-08-31, device manufacture date: 2018-09-10, medical device lot #: 8123881, medical device expiration date: 2023-05-31, device manufacture date: 2018-06-11, a device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It has been reported that the needle spinal s/su 25ga 3-1/2 in quincke has been found experiencing leakage during use.The following has been provided by the initial reporter: when introducing the device in the patients in order to perform the therapy on oncologic patients, it is observed the needle bends, occurring leakage of the cytotoxic medication.
Event or Problem Description
It has been reported that the needle spinal s/su 25ga 3-1/2in quincke has been found experiencing leakage during use.The following has been provided by the initial reporter: when introducing the device in the patients in order to perform the therapy on oncologic patients, it is observed the needle bends, occurring leakage of the cytotoxic medication.
Additional Manufacturer Narrative
H.6.Investigation: bd has not been provided with photos or samples for catalog 405180 lots 8219864 to investigate for this record.Unfortunately, as a result, bd was not able to verify the reported issue or determine a definitive root cause.The manufacturing records were reviewed for the incident lot and no discrepancies or non-conformances were reported that could have contributed to the reported condition of bent needle nor connectivity.Based on the device history report review, no malfunctions, such as jam, damage sensors were reported.Needles with angularity discrepancies above the specification should presents difficulties on the shield assembly process.Multiple inspection efforts were completed to comply with standards as part of acceptance criteria disposition.A corrective action plan, capa#(b)(4), has been implemented for the assembly, packing, storing and handling process.H3 other text : see h.10.

• 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: 9242221
• Report Number: 2618282-2019-00271
• Device Sequence Number: 16243016
• 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: distributor,foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2019

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: 405180
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/09/2019
• Supplement Date Received by Manufacturer: 10/09/2019
• Initial Report FDA Received Date: 10/25/2019
• Supplement Report FDA Received Date: 11/22/2019
• 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