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

Catalog Number	405181
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	08/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 was reported that bd¿ quincke spinal needle had foreign matter in the package.This was discovered before use.The following information was provided by the initial reporter: i allow myself to make novelty found in spinal needle no 22 x 3.50 in which in its sterile package has a hair.
Additional Manufacturer Narrative
Investigation: bd has been provided with a photo and sample for catalog 405181 lot 8337878 to investigate for this record.Visual examination of the photo and returned sample shows the foreign matter, in this case, a hair in the sealed package.As a result, bd was able to verify the reported issue.The investigation consisted of the review of the device history record for the reported lot, operating instructions, customer sample, test records and preventive maintenance records related to the spinal needle assembly and packaging process.The most probable cause of the reported issue is related to human factors for inappropriate gowning practices.
Event or Problem Description
It was reported that bd¿ quincke spinal needle had foreign matter in the package.This was discovered before use.The following information was provided by the initial reporter: i allow myself to make novelty found in spinal needle no 22x3.50 in which in its sterile package has a hair.

• Brand Name: BD¿ QUINCKE SPINAL NEEDLE
• Common Device Name: ANESTHESIA CONDUCTION NEEDLE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• MDR Report Key: 8921236
• Report Number: 2618282-2019-00240
• Device Sequence Number: 19365250
• Product Code: BSP
• UDI-Device Identifier: 30382904051816
• UDI-Public: 30382904051816
• 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): 09/12/2019

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: 12/31/2023
• Device Catalogue Number: 405181
• Device Lot Number: 8337878
• Initial Date Received by Manufacturer: 08/06/2019
• Supplement Date Received by Manufacturer: 08/06/2019
• Initial Report FDA Received Date: 08/22/2019
• Supplement Report FDA Received Date: 09/12/2019
• 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