MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 3ML LL W/NDL 21X1 RB; SYRINGE, PISTON

Catalog Number	309575
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Initial mdr submission.A follow up mdr will be submitted if a device evaluation and/or device history review is completed.Patient problem code: f26 ¿ no health consequences or impact device problem code: a0404 - crack.
Event or Problem Description
Material#: unknown batch#: unknown it was reported by the customer that here is the info for the 3ml syringes reported with cracks.3 ml bd luer-lok¿ syringe with attached needle 21 g x 1 in., sterile, single use.Our ir dept reported to us that item 56572 syringes have cracks/holes in the side of the syringe and when pressing the syringe the medication is leaking out of the side.I witnessed this happening.They found 4 just this morning leaking.Right now it¿s only been detected in one lot.Verbatim: rcc received a complaint via email.Email(s) attached.Here is the info for the 3ml syringes reported with cracks.3 ml bd luer-lok¿ syringe with attached needle 21 g x 1 in., sterile, single use.Our ir dept reported to us that item 56572 syringes have cracks/holes in the side of the syringe and when pressing the syringe the medication is leaking out of the side.I witnessed this happening.They found 4 just this morning leaking.Right now it¿s only been detected in one lot.Comments on (b)(6) 2023 1.Please provide the material number and batch number.Material # 309575 batch # 3135920 also, found a crack in 309575 batch # 3135922.2.Is there any sample available for investigation.Yes 3.Please confirm where the actual crack in barrel or in luer.Crack is in the barrel 4.Please confirm the particular location of leakage.Crack in the barrel 5.Please provide any available patient information including: age/ date of birth, sex, weight, ethnicity, race, other relevant history including preexisting medical conditions.Did not reach the patient 6.Date of event: 11/7 and (b)(6) 7.Did the event directly, or indirectly involve a patient or user? user 8.Did the event involve an urgent/life threatening medical situation? no 9.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.Please include treatment/intervention provided and the outcome.No patient harm 10.Did the event interrupt the administration of any medication, or cause a clinically significant delay in medication, that negatively impacted the patient? if yes, please provide details.Yes the second incident happened when the nurse was drawing up the medication.Medication was delayed approximately 5min, while the nurse got a new syringe.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
(b)(4)¿ follow up mdr for device evaluation a box containing six-hundred and seventy-two 3ml syringes with needle (model #309575) in sealed blister packages was received.Six hundred and seventy-one were from batch #3135920 and one was from batch #3241097, no samples were received for batch 3135922.The samples were visually evaluated.One sample was found to have a damaged flange appearing to have been scuffed downwards.One sample was heavily scraped across most of the printed surface and partially encompassed the barrel cylinder.One sample had several small cracks/imperfections between the 2ml and 2.5ml numerals on the printed scale.The scraped barrel and barrel with small cracks/imperfections were each leak tested under pressure per procedure and yielded acceptable results with no leakage observed.However, the scrapes and cracks were still non-conforming per product specification from a visual standpoint.The above noted samples were all from batch #3135920.The remaining samples and sole sample from batch #3241097 were acceptable per product specification.A device history record review was completed for provided batch numbers 3135920, 3135922, and 3241097 showing no rejected inspections or quality issues during the production of the provided lot numbers that could have contributed to the reported defect.Technical logs and production databases were also reviewed for the applicable timeframe as part of this investigation with no relevant notes found.Robust quality controls in the way of in-process inspection and testing to mitigate these types of defects are in place as part of our manufacturing process.Several factors can lead to barrel cracks from the marking to the assembly process.Potential root cause for the cracked barrel defect is associated with the scale marking process, this is due to the small cracks being printed over indicating the defect occurred prior to assembly potentially via a jam or feeding issue on the marking machine.Potential root cause for the scraped barrel and damaged flange defect is associated with the assembly process.It is likely an improper transfer between dials, or a machine jam improperly cleared led to the condition observed.The issue is likely limited to a small number of pieces as no assignable events or chronic issues with the manufacturing equipment could be deduced around the relevant timeframe.Additionally, no further complaints for the issue have been received for the noted lots.The samples received were not indicative of defects that would cause leakage under pressure as confirmed both visually and through leakage under pressure testing.It is unclear whether the samples that were evaluated were truly representative of what the customer reported.Photos or samples that clearly display the defect (leakage) as received by the customer are required for a more in-depth analysis.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.H3 other text : see h10 manufacture narrative.

• Brand Name: SYRINGE 3ML LL W/NDL 21X1 RB
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MDS DCHU; 75 north fairway drive; vernon hills IL 60061
• Manufacturer Contact: helen cox ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18269803
• Report Number: 1213809-2023-01394
• Device Sequence Number: 19806744
• Product Code: FMF
• UDI-Device Identifier: 30382903095750
• UDI-Public: (01)30382903095750
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2024

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: 309575
• Device Lot Number: 3135922
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2023
• Supplement Date Received by Manufacturer: 01/03/2024
• Initial Report FDA Received Date: 12/05/2023
• Supplement Report FDA Received Date: 01/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown