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

Model Number	305900
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that while using a bd safetyglide¿ safety injection needle, the needle was clogged.The following information was provided by the initial reporter: primary rn went to give pt an injection and the 22g im needle would not push.Rn pulled back upon initial injection to ensure i was in the right location without problem.Im needle wouldn't push.Rn removed needle changed it out with another 22g and had no problem.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 26-apr-2022.H.6.Investigation: one loose safetyglide needle (p/n 305900) with a strip of top web from batch 1266762 was received.The sample was visually evaluated under magnification.The cannula was observed to be clogged as no light visibly passed through.Additionally, the bottom of the cannula on the blunt side was observed to be clogged and debris appeared inside of the hub.The conditions observed at the packaging site were non-conforming per product specification.The sample was sent to the needle manufacturing site for further evaluation and investigation.At the needle manufacturing site, one sample was received.It has no plastic shield and the safety mechanism has been activated.A visual inspection was performed and inside of the needle hub residues of a yellowish dried substance observed, probably from the time it was used.A functional test was performed by connecting it to a syringe with saline solution.The solution was expelled with normal flow.No imperfections or defects were observed.A device history record review was completed for provided lot number 1266762.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.Based on the investigation and with the sample analysis the symptom reported by the customer could not be confirmed at the needle manufacturing site.
Event or Problem Description
It was reported that while using a bd safetyglide¿ safety injection needle, the needle was clogged.The following information was provided by the initial reporter: primary rn went to give pt an injection and the 22g im needle would not push.Rn pulled back upon initial injection to ensure i was in the right location without problem.Im needle wouldn't push.Rn removed needle changed it out with another 22g and had no problem.

• Brand Name: BD SAFETYGLIDE¿ SAFETY INJECTION 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: 14290267
• Report Number: 1213809-2022-00256
• Device Sequence Number: 1559585
• Product Code: FMI
• UDI-Device Identifier: 30382903059004
• UDI-Public: 30382903059004
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K951254
• 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): 05/23/2022

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: Health Professional
• Device Expiration Date: 09/30/2026
• Device Model Number: 305900
• Device Catalogue Number: 305900
• Device Lot Number: 1266762
• 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: 04/11/2022
• Supplement Date Received by Manufacturer: 05/23/2022
• Initial Report FDA Received Date: 05/05/2022
• Supplement Report FDA Received Date: 06/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2021
• 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