MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 1ML S/T W/NDL 21X1 RB; PISTON SYRINGE

Catalog Number	309624
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	06/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
Materials#: 309624 batch#: 9214045 it was reported that the bd syringe 1ml s/t w/ndl 21x1 rb shield was tight resulting in a contaminated needle stick.The following information was provided by the initial reporter: sheath covering needle impossible to remove.Excess forced used to remove cover which led to needle stick through contaminated glove.Item - 309624.Lot - 9214045.Additional information provided: the needle stick happened before use of that syringe.1ml tb syringe with needle was sterile when needle stick occurred during the removal of the plastic sheath covering the needle.The needle however pierced the glove at the site of blood contamination and into users left index finger.User reported to health center for medical intervention and blood was drawn for a baseline for hep c and hiv.
Additional Manufacturer Narrative
(b)(4) follow up report for device evaluation.Since no samples displaying the condition reported are available for examination, we were unable to fully confirm this incident.No root cause can be determined as no samples were received.Furthermore, 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.Examination of the product involved may provide clarification as to the cause for the reported failure.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
No additional information was provided.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
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.Furthermore, 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.We would be very interested in examining product that does not meet your expectations and our quality standards.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.Examination of the product involved may provide clarification as to the cause for the reported failure.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
Additional Manufacturer Narrative
(b)(4) follow up report for correction.Following the submission of the initial mdr, it was determined that the reported event does not meet the criteria per the fda for a reportable serious injury; the needlestick was not treated medically or surgically to prevent permanent impairment.Adverse type was incorrect in the initial mdr, adverse type should be product problem only.Type of reportable event was incorrect in the initial mdr, type of reportable event should be malfunction.
Event or Problem Description
No additional information provided.
Additional Manufacturer Narrative
Becton dickinson and company's (bd) medication delivery solutions (mds) business unit will discontinue malfunction mdr reporting for certain device failures that have not caused or contributed to deaths or serious injuries in the past two years, and where the likelihood of a death or serious injury as a result of these malfunctions is remote.This decision follows fda guidelines (medical device reporting for manufacturers guidance for industry and food and drug administration staff issued nov 8, 2016, reference section 2.15).Bd notified fda of this decision on mar 3, 2025.Fda has reviewed and responded to bd¿s notification (reference fda document # (b)(4)) on march 7, 2025.This documentation is available in bd document management system (sap) as (b)(4).This supplemental mdr is being filed to document that the below device failure will no longer be considered a reportable malfunction mdr for the product family below: product family: conventional syringe - 0.5-10ml.Device failure: cap / shield tight.
Event or Problem Description
No additional information.

• Brand Name: BD SYRINGE 1ML S/T W/NDL 21X1 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: 19706873
• Report Number: 1213809-2024-00434
• Device Sequence Number: 6587600
• Product Code: FMF
• UDI-Device Identifier: 30382903096245
• UDI-Public: (01)30382903096245(11)190802(17)240731(10)9214045
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,Followup,Followup,Followup
• Report Date (Section B): 03/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 07/31/2024
• Device Catalogue Number: 309624
• Device Lot Number: 9214045
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2024
• Supplement Date Received by Manufacturer: Not provided; 07/23/2024; Not provided; Not provided
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 07/22/2024; 08/14/2024; 01/21/2025; 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown