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

Model Number	405180
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)
Date of Event	01/29/2020
Type of Reportable Event	Serious Injury
Additional 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.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trend investigation conclusion: bd was not able to duplicate or confirm the customer¿s indicated failure as no sample, batch, or lot code was provided.Root cause description: root cause is undetermined.Rationale: no sample, lot, or batch provided.
Event or Problem Description
It was reported that while using the bd needle spinal s/su 25ga 3-1/2in quincke the healthcare provider received a contaminated needle stick.Verbatim: it was reported that a needle stick injury occurred on the clinician after having used the needle on the patient.In this occurrence the clinician recapped the needle after using it, then went to use it again and the needle recoiled and stuck the tech.In this needle stick occurrence, clinician used the needle on the patient, recapped it and were going to use it again when the needle 'recoiled' and stuck the tech.

• Brand Name: BD NEEDLE SPINAL S/SU 25GA 3-1/2IN QUINCKE
• Common Device Name: SPINAL NEEDLE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• MDR Report Key: 9676627
• Report Number: 2618282-2020-00005
• Device Sequence Number: 2773916
• Product Code: BSP
• UDI-Device Identifier: 30382904051809
• UDI-Public: 30382904051809
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/03/2020

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: Health Professional
• Device Model Number: 405180
• Device Catalogue Number: 405180
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2020
• Initial Report FDA Received Date: 02/06/2020
• 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