MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD HYPODERMIC NEEDLE PRECISIONGLIDE¿ 3 ML 22 G; PISTON SYRINGE

Catalog Number	309569
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd hypodermic needle precisionglide¿ 3 ml 22 g damage to the needle hub was noticed during use.There was no report of patient impact.The following information was provided by the initial reporter: it was reported by the customer that the needle hub was causing air ender the hub instead of suction associate noticed the needle hub was causing air ender the hub instead of suction.Was preventing from drawing blood properly and administering vaccine.Lot.1244915 event date: (b)(6) 2022.Bd notified date: (b)(6) 2022.
Event or Problem Description
It was reported while using bd hypodermic needle precisionglide¿ 3 ml 22 g damage to the needle hub was noticed during use.There was no report of patient impact.The following information was provided by the initial reporter: it was reported by the customer that the needle hub was causing air ender the hub instead of suction.Associate noticed the needle hub was causing air ender the hub instead of suction.Was preventing from drawing blood properly and administering vaccine.Lot.1244915.Event date: 5/9/2022.Bd notified date: 5/11/2022.
Additional Manufacturer Narrative
H6: investigation summary: eleven samples of 3ml luer-lock syringes (p/n 309569) batch 1244915 in sealed package were received and evaluated.A visual inspection performed, no damage observed.A testing was performed, no problem drawing up fluid and no leaks were observed to exist in the syringe or the needle hub.The reported defect was not identified in the samples received; therefore, no corrective actions are necessary.A device history record review was completed for provided lot number 1244915.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.

• Brand Name: BD HYPODERMIC NEEDLE PRECISIONGLIDE¿ 3 ML 22 G
• Common Device Name: PISTON SYRINGE
• 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: 14623547
• Report Number: 1213809-2022-00321
• Device Sequence Number: 12047126
• Product Code: FMF
• UDI-Device Identifier: 00382903095698
• UDI-Public: 00382903095698
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• 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): 06/29/2022

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: 08/31/2026
• Device Catalogue Number: 309569
• Device Lot Number: 1244915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2022
• Supplement Date Received by Manufacturer: 06/29/2022
• Initial Report FDA Received Date: 06/07/2022
• Supplement Report FDA Received Date: 07/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2021
• 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