MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD¿ LUER SLIP TIP SYRINGE WITH ATTACHED NEEDLE 26 G X 5/8 IN; PISTON SYRINGE

Catalog Number	309597
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Hot Flashes/Flushes (2153)
Date of Event	03/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.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 usingbd¿ luer slip tip syringe with attached needle 26 g x 5/8 in the needle pulled out of the hub.There was no report of patient impact.The following information was provided by the initial reporter: called to report, "it was the needle that you draw the medication up with, the 1 ml subq syringe in the kit.The needle piece was very loose and when she injected the patient, she went to pull it out and the needle stayed in him, but the whole syringe barrel removed when she was going to pull it out".Is there any adverse event for patient/user? yes.Adverse event was reported while injecting product, the patient experienced a burning sensation.No further information available.What kind of medication used during the incident? gattex.
Additional Manufacturer Narrative
Investigation summary: 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.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.
Event or Problem Description
It was reported while usingbd¿ luer slip tip syringe with attached needle 26 g x 5/8 in the needle pulled out of the hub.There was no report of patient impact.The following information was provided by the initial reporter: called to report."it was the needle that you draw the medication up with, the 1 ml subq syringe in the kit.The needle piece was very loose and when she injected the patient, she went to pull it out and the needle stayed in him, but the whole syringe barrel removed when she was going to pull it out." is there any adverse event for patient/user? yes, adverse event was reported.While injecting product, the patient experienced a burning sensation.No further information available.What kind of medication used during the incident? gattex.

• Brand Name: BD¿ LUER SLIP TIP SYRINGE WITH ATTACHED NEEDLE 26 G X 5/8 IN
• 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 ; 8448235433
• MDR Report Key: 16777748
• Report Number: 1213809-2023-00384
• Device Sequence Number: 6867792
• Product Code: FMF
• UDI-Device Identifier: 00382903095971
• UDI-Public: (01)00382903095971
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• 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): 04/27/2023

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 Catalogue Number: 309597
• Device Lot Number: 2131738
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2023
• Supplement Date Received by Manufacturer: 04/27/2023
• Initial Report FDA Received Date: 04/20/2023
• Supplement Report FDA Received Date: 05/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2022
• 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