MAUDE Adverse Event Report: BD CARIBE LTD. SPINAL NEEDLE BD¿ QUINCKE; ANESTHESIA CONDUCTION NEEDLE

Catalog Number	405184
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Investigation summary: the manufacturing records for sub-assembly lot 7096881 and/or final lot 7111829 were reviewed and no events or non-conformances were reported that could have contributed to the reported condition.The results of the pull test inspections from in process and final inspections were with the specification requirements of 12 pounds minimum.Evaluation of the picture included in the complaint was performed by quality and engineering representatives and during this process, it was identified that the complaint description stated needle was separated from the hub during bone marrow procedure.As per product circular, pc100406 rev.08, the bd spinal needles are intended for spinal anesthesia.Based on this statement, the spinal needle is not intended for bone marrow procedure.The most probable cause of the plastic hub became disconnected from the needle portion is related to product misuse.As a result, we cannot verify the reported issue.Investigation conclusion: conclusion: not confirmed: bd was not able to confirm the customer¿s indicated failure mode as associated with the manufacturing process.As per product circular, pc100406 rev.08, the bd spinal needles are intended for spinal anesthesia.Based on this statement, the spinal needles are not intended for bone marrow procedure.Root cause description the most probable cause of the plastic hub became disconnected from the needle portion is related to product misuse.A review of the device history record was completed for lot #7111829.Product was manufactured from 12apr2017 to 17apr2017 on insert molded machine (b)(4) under sub-assembly part number 700005930 lot 7096881 order# (b)(4).In process inspections as per (b)(4) are performed at shift start up 32 samples (8 p/cavity) and every 4 hours 16 samples (4 p/cavity) including visual characteristics, dimensional and functional.As part of the functional inspections, pull test was performed to assure cannula does not disengage from hub.The specification is 12 pounds minimum and the reported results in (b)(4) were between 17.5lbs minimum to 42.8lbs maximum.Final inspection by quality was performed on 18apr2017 including pull test on 20 samples (s3 single sampling) as per (b)(4).According to the inspection record (b)(4), samples reported values from 29.06lbs minimum to 36.62lbs maximum which were in compliance with the specification.Lot was released for packaging 20apr2017 and packed on multivac machine during 25apr2017-26apr2017 as ns405184 lot 7111829 order# (b)(4).In process inspections according (b)(4) and final quality inspection (b)(4) on 26apr2017 passed with satisfactory results.No machine interventions, breakdowns, qn¿s and/or ncmrs were reported for sub-assembly lot 7096881 and/or final lot 7111829.Lot 7111829 was released for shipping 27apr2017 and sterilization released approved on 19may17.The expiration date is 31apr2022.Preventive maintenance on the (b)(4) and multivac machines were conducted as per schedule.Review of instrument calibrations included in the inspection records was conducted and they were calibrated within their calibration due dates.Evaluation of the picture included in the complaint was performed by quality and engineering representatives.During this process, it was identified that the complaint description stated needle was separated from the hub during bone marrow procedure.As per product circular, pc100406 rev.08, the bd spinal needles are intended for spinal anesthesia.Based on this statement, the spinal needle is not intended for bone marrow procedure.Capa determination results: per (b)(4), bd corrective and preventive action (capa) corporate procedure, the reported issue does not represent a single significant incident that would trigger a capa.Severity: s1 occurrence: 1st investigation level: a related complaints: n/a.
Event or Problem Description
It was reported that during use a spinal needle bd¿ quincke malfunctioned as ¿during a bone marrow procedure, the needle become lodged/stuck.Unable to remove easily, the plastic hub became disconnected from the needle portion which remained inserted (patient end).The product was removed manually with some minor manual force by a member of the clinical team using a pair of gloves for extra grip.There was no report of injury or medical intervention reported.

• Brand Name: SPINAL NEEDLE BD¿ QUINCKE
• Common Device Name: ANESTHESIA CONDUCTION NEEDLE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• MDR Report Key: 7310126
• Report Number: 2618282-2018-00005
• Device Sequence Number: 2116813
• Product Code: BSP
• UDI-Device Identifier: 30382904051847
• UDI-Public: 30382904051847
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Type of Report: Initial
• Report Date (Section B): 02/07/2018

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: 04/30/2022
• Device Catalogue Number: 405184
• Device Lot Number: 7111829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2018
• Initial Report FDA Received Date: 03/02/2018
• 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