MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL NEEDLE 21X1-1/4 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305166
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter address: (b)(6).Medical device expiration date: unknown.(b)(4).Investigation summary: five photos were provided for evaluation.They showed the packaging and labeling confirming the product and lot# as well as the symptom reported.This lot was produced ten years ago; at that time, the expiration date was not required to print it on the labels.The customer has an expired product.Based on the investigation carried out, and the photo sample analysis, the reported symptom is confirmed.It is recommended that hypodermic marketing informs the customer that they have expired products.The batch history review could not be completed as this lot was produced ten years ago.According to our procedure, the records are kept for seven years.Complaints received for this device and reported condition would 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 the identification of emerging trends.Investigation conclusion: this is the 1st complaint for lot #1013558 for this type of defect or symptom.Batch record review was not possible to be performed., per procedure the records are kept for 7 years.This lot was produced 10 years ago.Based on the investigation carried out and with the photo sample analysis the symptom reported by the customer is confirmed.It is recommend that hypodermic marketing informs the customer they have expired product.Root cause description: the customer has expired product.Rationale: capa not required at this time.A review of the applicable fmea/eura (peura(b)(4) indicates that the potential risk of the reported event was assessed appropriately in the risk management documentation.
Event or Problem Description
It was reported that 5 needles 21 x 1-1/4 rb were missing an expiration date.The following information was provided by the initial reporter: "no physical expiry date pre-printed on the carton boxes.".

• Brand Name: NEEDLE 21X1-1/4 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: 10412993
• Report Number: 1911916-2020-00741
• Device Sequence Number: 2392381
• Product Code: FMI
• UDI-Device Identifier: 30382903051664
• UDI-Public: 30382903051664
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K021475
• 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
• Report Date (Section B): 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 305166
• Device Catalogue Number: 305166
• Device Lot Number: 1013558
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2020
• Initial Report FDA Received Date: 08/17/2020
• 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