MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 1ML S/T W/NDL 25X5/8 RB; PISTON SYRINGE

Catalog Number	309626
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.The date received by manufacturer has been used for this field.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd syringe 1ml s/t w/ndl 25x5/8 rb had leakage.The following information was provided by the initial reporter: "during the inject the medication is leaking from the hub so the patients are not getting the full vaccine.They are having to re-stick the patients to make sure they get the vaccine.When they draw up the medication and they have to recap the needle, they have had 2 needle sticks due to the bevel penetrating the cap.2 clean needles last month last and, in the fall, not sure of the days.Nurses just cleaned it off and covered.(b)(6) faulty syringe material 309626 lot 3058292, 3150938, 2341837, 3048203 during the inject the medication is leaking from the hub so the patients are not getting the full vaccine.They are having to restick the patients to make sure they get the vaccine.When they draw up the medication and they have to recap the needle, they have had 2 needle sticks due to the bevel penetrating the cap.2 clean needles last month last and in the fall not sure of the days.Nurses just cleaned it off and covered.Customer does have the samples available for the investigation.They order from concordance health and would like credit for 20 boxes, does not have a po.
Event or Problem Description
Material #: 309626 batch#: 3058292, 3150938, 2341837, 3048203.It was reported by customer that during the inject the medication is leaking from the hub so the patients are not getting the full vaccine.They are having to re-stick the patients to make sure they get the vaccine.When they draw up the medication and they have to recap the needle, they have had 2 needle sticks due to the bevel penetrating the cap.2 clean needles last month last and, in the fall, not sure of the days.Nurses just cleaned it off and covered.Verbatim: rcc received a complaint via mail.Pir attached.(b)(6).Faulty syringe material 309626 lot 3058292, 3150938, 2341837, 3048203.During the inject the medication is leaking from the hub so the patients are not getting the full vaccine.They are having to restick the patients to make sure they get the vaccine.When they draw up the medication and they have to recap the needle, they have had 2 needle sticks due to the bevel penetrating the cap.2 clean needles last month last and in the fall not sure of the days.Nurses just cleaned it off and covered.Customer does have the samples available for the investigation.They order from concordance health and would like credit for 20 boxes, does not have a po.
Additional Manufacturer Narrative
Twelve samples and three photos of 1ml luer-slip syringes w/25x5/8" needles attached (material #309626) were received and evaluated.Three syringe each from lots 2341837, 3048203, 3058292, & 3150938 were received in sealed packages with all applicable product information on the top web.All 12 samples were tested for leakage and found acceptable without leakage.The condition observed is acceptable per product specification.One of the photos shows an unsealed package with applicable product information visible.Another photo shows a loose needle with the cannula bent and puncturing the shield.The next image shows a loose syringe with the scale markings grossly skewed and partially missing.The condition observed is non-conforming per product specification.The reported leakage defect was not identified in the samples received.It is recommended to hand tighten the needle onto the syringe prior to use.Potential root cause for the scale markings defects is associated with the marking process.Potential root cause for the needle through shield defect is associated with the needle supplier¿s manufacturing process.The photos will be forwarded to the needle supplier for further evaluation and investigation.A device history record review was completed for provided lot numbers 2341837, 3048203, 3058292, & 3150938 showing no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.

• Brand Name: BD SYRINGE 1ML S/T W/NDL 25X5/8 RB
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18784121
• Report Number: 1213809-2024-00113
• Device Sequence Number: 12836275
• Product Code: FMF
• UDI-Device Identifier: 30382903096269
• UDI-Public: (01)30382903096269
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• 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,Followup
• Report Date (Section B): 04/25/2024

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: 309626
• Device Lot Number: 3058292
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2024
• Supplement Date Received by Manufacturer: 04/25/2024
• Initial Report FDA Received Date: 02/26/2024
• Supplement Report FDA Received Date: 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown