MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL NEEDLE 26X5/8 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305115
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.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: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.This is the 1st complaint for lot # 9193542 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: a mis-assembly at the cannulation operation causes a double cannula.A needle misses the hub, and falls on to the adjacent needle on the rack.If the operator does not see it, the epoxy cures, and the second cannula sticks to the assembled needle.The dvt camera that inspects for epoxy may catch this defect if the defect is on the side facing the camera.It is essentially the responsibility of the assembly associate to monitor for these defects, correct the issue, and remove the affected needles.Rationale: based on the investigation, no additional investigation and no capa is required at this time.
Event or Problem Description
It was reported that an extra needle 26x5/8 rb was found pierced through the needle cover before use.The following information was provided by the initial reporter: "an extra needle is within the cap of the existing needle and is poking out the top.".
Additional Manufacturer Narrative
H.6 investigation summary: one sample was received.The sample was visually inspected.It has an extra needle adhered to the plastic hub.A mis-assembly at the cannulation operation causes a double cannula.A needle misses the hub, and falls on to the adjacent needle on the rack.If the operator does not see it, the epoxy cures, and the second cannula sticks to the assembled needle.The dvt camera that inspects for epoxy may catch this defect if the defect is on the side facing the camera.It is essentially the responsibility of the assembly associate to monitor for these defects, correct the issue, and remove the affected needles.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.
Event or Problem Description
It was reported that an extra needle 26x5/8 rb was found pierced through the needle cover before use.The following information was provided by the initial reporter: "an extra needle is within the cap of the existing needle and is poking out the top".

• Brand Name: NEEDLE 26X5/8 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: 9630109
• Report Number: 1911916-2020-00045
• Device Sequence Number: 2487990
• Product Code: FMI
• UDI-Device Identifier: 30382903051152
• UDI-Public: 30382903051152
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2020

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: 09/30/2024
• Device Model Number: 305115
• Device Catalogue Number: 305115
• Device Lot Number: 9193542
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 01/16/2020
• Initial Report FDA Received Date: 01/24/2020
• Supplement Report FDA Received Date: 02/28/2020
• 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