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

Model Number	305906
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd safetyglide¿ shielding hypodermic needle experienced damaged packaging where sterility was compromised.The following information was provided by the initial reporter: during our picking process, we noted that two of the syringes were stuck together as there was a loose needle lodged through the inside packaging of two needles.
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, returned to manufacturer on: 25-oct-2022.Investigation summary: one sample was provided to our quality team for investigation.Through visual inspection, it was observed that the sample have two packages with a syringe and shielded needle in each package and one separate needle observed in one package and stretched across to the other package causing a void in the seal on both packages.The condition observed is non-conforming per product specification.Potential root cause for the packaging integrity defect is associated with the packaging process.These conditions are occurring below their expected frequency so no corrective action is required at this time.Furthermore, a device history record review was completed for provided lot number 9346458.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.
Event or Problem Description
It was reported that the bd safetyglide¿ shielding hypodermic needle experienced damaged packaging where sterility was compromised.The following information was provided by the initial reporter: during our picking process, we noted that two of the syringes were stuck together as there was a loose needle lodged through the inside packaging of two needles.

• Brand Name: BD SAFETYGLIDE¿ SHIELDING HYPODERMIC NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15670707
• Report Number: 1213809-2022-00792
• Device Sequence Number: 6372103
• Product Code: FMI
• UDI-Device Identifier: 30382903059066
• UDI-Public: 30382903059066
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K992734
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2022

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 Expiration Date: 11/30/2024
• Device Model Number: 305906
• Device Catalogue Number: 305906
• Device Lot Number: 9346458
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2022
• Supplement Date Received by Manufacturer: 11/09/2022
• Initial Report FDA Received Date: 10/25/2022
• Supplement Report FDA Received Date: 11/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown