MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD HYPODERMIC PRECISIONGLIDE NEEDLE WITHOUT SAFETY; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305156
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 8331606.Medical device expiration date: 2024-01-31.Device manufacture date: 2018-11-27.Medical device lot #: 9099872.Medical device expiration date: 2024-03-31.Device manufacture date: 2019-04-09.Investigation summary: no sample was provided.Since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.Examination of the product involved may provide clarification as to the cause for the reported failure.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.Based on no sample, the investigation concluded, bd was not able to verify the indicated failure.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 #s 8331606, 9099872 for this type of defect or symptom.There was no documentation for this type of defects during the entire production run of these batch numbers.Root cause description: root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.Rationale: capa not required at this time.
Event or Problem Description
It was reported that the bd¿ hypodermic precisionglide¿ needle without safety came off the syringe when drawing up medication during use.The needle also came off when injecting into the skin, but no doses were missed.Lot#'s 8331606 and 9099872 were reported to have been involved in this event, but it is unknown how many occurrences happened within each.The following information was provided by the initial reporter: "patient reported when preparing the medication the needle is pushed on the syringe and then used to draw up the medication.When drawing up the medication the needle will come off.The caller stated the patient also reported that when the needle is injected into the skin it will come off.The caller confirmed there are no missed doses.".

• Brand Name: BD HYPODERMIC PRECISIONGLIDE NEEDLE WITHOUT SAFETY
• 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: 9759636
• Report Number: 1911916-2020-00188
• Device Sequence Number: 19560721
• Product Code: FMI
• UDI-Device Identifier: 30382903051565
• UDI-Public: 30382903051565
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 02/17/2020

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 Model Number: 305156
• Device Catalogue Number: 305156
• Device Lot Number: SEE SECTION H.10.
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2020
• Initial Report FDA Received Date: 02/26/2020
• 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