MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY NEEDLE 20X1-1/2 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305176
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Device evaluated by mfr: 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 sterile breach occurred with a needle 20x1-1/2 rb.The following information was provided by the initial reporter, " as part of an ongoing investigation into a sterility positive, we are contacting the supplier of sterile materials used in our process.Could you please tell me if there have been any complaints, field issues, or manufacturing deviations with the following items?" 1 of 3 complaints.
Event or Problem Description
It was reported that sterile breach occurred with a needle 20x1-1/2 rb.The following information was provided by the initial reporter, " as part of an ongoing investigation into a sterility positive, we are contacting the supplier of sterile materials used in our process.Could you please tell me if there have been any complaints, field issues, or manufacturing deviations with the following items?" 1 of 3 complaints.
Additional Manufacturer Narrative
Investigation: no samples or photos were provided by the customer for investigation.A device history record (dhr) review was performed on the batch associated with this investigation.The dhr reviews did not reveal any defects or issues reported and no quality notifications were issued.Based on the investigation conclusion and without a sample to analyze, the condition reported by the customer could not be confirmed nor could this symptom be correlated with a potential cause linked to the bd process.

• Brand Name: NEEDLE 20X1-1/2 RB
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY; 2153 12th avenue; columbus NE 68601
• MDR Report Key: 8671574
• Report Number: 1911916-2019-00565
• Device Sequence Number: 14040642
• Product Code: FMI
• UDI-Device Identifier: 30382903051763
• UDI-Public: 30382903051763
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2019

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: 06/30/2023
• Device Catalogue Number: 305176
• Device Lot Number: 8090596
• Initial Date Received by Manufacturer: 05/20/2019
• Supplement Date Received by Manufacturer: 05/20/2019
• Initial Report FDA Received Date: 06/05/2019
• Supplement Report FDA Received Date: 06/17/2019
• 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