MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD¿ NEEDLE 21X2 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305129
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.Medical device expiration date: unknown.(b)(6).Initial reporter: address unavailable.Bd corporate address used.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that label is missing with a bd¿ needle 21x2 rb.The following information was provided by the initial reporter: it was reported the master carton label is missing.
Event or Problem Description
It was reported that label is missing with a bd¿ needle 21x2 rb.The following information was provided by the initial reporter: it was reported the master carton label is missing.
Additional Manufacturer Narrative
H.6.Investigation: the photos provided by the customer were not able to be opened by bd, therefore sample analysis could not be performed and the condition reported by the customer could not be confirmed.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.A device history record (dhr) review was not performed on the batch associated with this investigation as the batch number is not known.

• Brand Name: BD¿ NEEDLE 21X2 RB
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 8584460
• Report Number: 1911916-2019-00448
• Device Sequence Number: 1586970
• Product Code: FMI
• UDI-Device Identifier: 30382903051299
• UDI-Public: 30382903051299
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 05/20/2019

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 Catalogue Number: 305129
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 04/19/2019
• Supplement Date Received by Manufacturer: 04/19/2019
• Initial Report FDA Received Date: 05/06/2019
• Supplement Report FDA Received Date: 05/20/2019
• 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