MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD PRECISIONGLIDE NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305159
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: 1990 samples were received.They all came in sealed packaging blisters.The top web shows the graphics dg34602.Where the description shows a 22g x 1 ½ (0.7mm x 40mm) at the center and at one edge has a perpendicular black strip with white text stating 22g x 1 ½ (0.7 mm x 30mm).Information in the graphics are not consistent.New graphics have been released.Dg34604 are not active and do not have this problem.Complaints received for this device and reported condition will 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 identification of emerging trends.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.Investigation conclusion: this is the 1st complaint for lot # 9078977 for this type of defect or symptom.There was no documentation for this type of defect during the entire production run of this batch.Root cause description: information in the graphics are not consistent.New graphics have been released.Dg34604 are not active and do not have this problem.Rationale: capa not required at this time.
Event or Problem Description
It was reported that the bd precisionglide¿ needle's old label stated it was a "22gx 1.5 x 30mm" on the side tab, and "22gx 1.5 x 40mm" beneath the brand name.However, the new label showed it as a "22gx 1.5 x 40mm" without the side tab labeling.This was noticed before use in lot# 9078977.The following information was provided by the initial reporter: "we received in lot (9078977) and your description states they are 22gx 1.5 x 40mm, however, the tab is stating they are 22g x 1.5" x 30mm.In the attachments, second one is now showing your new labeling without the tab.So going forward, only one size listed.We did not notice this at qa inspection, however, caught on the production floor so i have a total of 3,368 units of lot 9078977.".
Additional Manufacturer Narrative
Correction: the date of event has been provided by the customer.The following information has been updated: b.3.Date of event: (b)(6) 2020.
Event or Problem Description
It was reported that the bd precisionglide¿ needle's old label stated it was a "22gx 1.5 x 30mm" on the side tab, and "22gx 1.5 x 40mm" beneath the brand name.However, the new label showed it as a "22gx 1.5 x 40mm" without the side tab labeling.This was noticed before use in lot# 9078977.The following information was provided by the initial reporter: "we received in lot (9078977) and your description states they are 22gx 1.5 x 40mm, however, the tab is stating they are 22g x 1.5" x 30mm.In the attachments, second one is now showing your new labeling without the tab.So going forward, only one size listed.We did not notice this at qa inspection, however, caught on the production floor so i have a total of (b)(4) units of lot 9078977".

• Brand Name: BD PRECISIONGLIDE NEEDLE
• 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: 9759635
• Report Number: 1911916-2020-00189
• Device Sequence Number: 2910147
• Product Code: FMI
• UDI-Device Identifier: 30382903051596
• UDI-Public: 30382903051596
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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): 03/04/2020

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: 04/30/2024
• Device Model Number: 305159
• Device Catalogue Number: 305159
• Device Lot Number: 9078977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2020
• Initial Date Received by Manufacturer: 02/18/2020
• Supplement Date Received by Manufacturer: 02/18/2020
• Initial Report FDA Received Date: 02/26/2020
• Supplement Report FDA Received Date: 03/04/2020
• 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