MAUDE Adverse Event Report: BD CARIBE LTD. NEEDLE EPIDURAL S/SU 18GA 3-1/2IN WEISS; ANESTHESIA CONDUCTION NEEDLE

Model Number	405188
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 400 needles epidural s/su 18ga 3-1/2in weiss were found before use with foreign particles in them.The following information was provided by the initial reporter, translated from spanish to english: "material with foreign particles.".
Additional Manufacturer Narrative
H.6 investigation summary: three photos were received by our quality team for evaluation.Upon visual inspection, the photos show one unused blister package containing a epidural needle and foreign matter was observed to be present but it cannot be confirmed what type of substance or particle it is from the photo.In addition, with photos provided it cannot be identified if foreign matter is inside or outside the blister.The incident could be verified but since no actual samples were provided for evaluation it was not possible to determine the type of particle or its possible sources.The investigation consisted of the review of the device history record for the reported lot, operating instructions, customer photo, test records and preventive maintenance records related to the spinal needle assembly and packaging process.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.All process and final inspections for this lot were performed with acceptable results.In addition, no process issues that may have contributed to the reported issue were reported during this run.Awareness of the complaint was provided to manufacturing via email to the supervisors and team leaders.Based on the limited information provided for the investigation, a possible root cause could not be determined within the scope of this evaluation.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that 400 needles epidural s/su 18ga 3-1/2in weiss were found before use with foreign particles in them.The following information was provided by the initial reporter, translated from spanish to english: "material with foreign particles.".

• Brand Name: NEEDLE EPIDURAL S/SU 18GA 3-1/2IN WEISS
• Common Device Name: ANESTHESIA CONDUCTION NEEDLE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• MDR Report Key: 9861003
• Report Number: 2618282-2020-00025
• Device Sequence Number: 3257845
• Product Code: BSP
• UDI-Device Identifier: 30382904051885
• UDI-Public: 30382904051885
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• 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): 04/15/2020

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: Other
• Device Expiration Date: 01/31/2024
• Device Model Number: 405188
• Device Catalogue Number: 405188
• Device Lot Number: 9018553
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/29/2020
• Supplement Date Received by Manufacturer: 02/29/2020
• Initial Report FDA Received Date: 03/20/2020
• Supplement Report FDA Received Date: 04/20/2020
• 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