MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SAFETYGLIDE NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305921
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.Initial reporter state: address information was not able to be obtained.(b)(6) was used as a place holder.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.(b)(4).
Event or Problem Description
It was reported that prior to use the label is discovered missing from back of 10 package with a bd safetyglide¿ needle.The following information was provided by the initial reporter: individual items are supposed to have label info on the back plastic wrap and when received.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10 device available for eval yes.D.10 returned to manufacturer on: 2020-07-21.Investigation summary: four strips of 5 safetyglide needles were received and visually evaluated.Each strip of 5 had progressively less top web print, with one strip missing almost all information on the web.From the strips that contained some information it was possible to discern partial batch # 00024 with the last two digits likely being 01.Catalog number was confirmed to be 305921.This information was cross-referenced with production timeline to verify that the batch # was highly likely 0002401 for this product.Missing and/or illegible top web print is a rejectable condition per product specification.All visual inspections were performed as per requirement.The defect was found during the manufacture of this batch.Product was stopped, adjustments were made and product requalified per applicable aql.However, no quality notification was issued.Batch 0002401 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Adjustments to print heads were recorded in the dhr to address the defect that matched the one observed in the returned customer samples.There were 2 potential root causes.Equipment failure during packaging process.There was a recorded issue with the top web printer that was detected during production.Insufficient containment of defect.Requalification criteria will be tightened for potential future instances of top web print defects.The due date for these corrective actions are 18sep2020.
Event or Problem Description
It was reported that prior to use the label is discovered missing from back of 10 package with a bd safetyglide¿ needle.The following information was provided by the initial reporter: individual items are supposed to have label info on the back plastic wrap and when received.

• Brand Name: BD SAFETYGLIDE NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 10253521
• Report Number: 1213809-2020-00452
• Device Sequence Number: 3399382
• Product Code: FMI
• UDI-Device Identifier: 30382903059219
• UDI-Public: 30382903059219
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K951254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other,user facili
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2020

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: 305921
• Device Catalogue Number: 305921
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2020
• Initial Date Received by Manufacturer: 06/18/2020
• Supplement Date Received by Manufacturer: 06/18/2020
• Initial Report FDA Received Date: 07/09/2020
• Supplement Report FDA Received Date: 07/30/2020
• 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