MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 16X1 RB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305197
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial mdr submission with device evaluation.A device history record review was completed by our quality engineer team for provided material number 305197 and lot number 3320201.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.There are quality controls currently in place to detect this type of defect during the production process.Further action has not been determined necessary at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
Material: 305197 batch#: 3320201 it was reported by the customer that stated that the needles would bend, split, and snap off during use allowing the drugs to leak out.Verbatim: rcc received a complaint via phone.Pir attached mckesson¿s product safety review team received a product complaint: 03/07/2024: xxxxx customer service specialist at the xxxx (dc 8183) reported to the product safety review team (psrt) that on 03/07/2024 a customer, xxxx, reported five (5) 100-count boxes of 16g needles (upc 08290305197)(lot 3320201), manufactured by xxxx, where the needles were defective.Xxxx stated that the needles would bend, split, and snap off during use allowing the drugs to leak out.One (1) whole box had been thrown away already and xxx still has four (4) boxes.Xxxx instructed xxx to report the event to the manufacturer.Xxxx stated that they were unsure how to report the event to the manufacturer, however they did confirm that the boxes showed no signs of tampering.Xxx stated that the manufacturer would be contacted and asked shanice to keep the product quarantined.

• Brand Name: NEEDLE 16X1 RB
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19238866
• Report Number: 1911916-2024-00306
• Device Sequence Number: 20851119
• Product Code: FMI
• UDI-Device Identifier: 30382903051978
• UDI-Public: (01)30382903051978
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/18/2024

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: Health Professional
• Device Catalogue Number: 305197
• Device Lot Number: 3320201
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2024
• Initial Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown