MAUDE Adverse Event Report: BECTON DICKINSON BD SYRINGE 3ML LL W/NDL ECLIPSE 25X1; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305787
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd syringe 3ml ll w/ndl eclipse 25x1 stopper was defective / damage / deformed the following information was provided by the initial reporter: verbatim: rcc received a complaint via email.Email(s) attached.Case is manually created since the manual entry needed based on the daily intake report 29 nov 2023 (error tracking tab) (email was forwarded to aei on 28 nov 2023 but aei failed to create the case) the stopper sticks halfway through administering meds; was injecting patients when issue occurred; between 3-5 affected; both female and male; no adverse affects.Failure to deliver.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
Based on device history record review, no abnormality was observed during the production of the affected batches.Review of the dhr showed that the silicone content results are within specification with no abnormality observed.Actual root cause could not be determined as no sample were received for investigation.The complaint will be re-opened and re-investigated when sample is received.
Event or Problem Description
Material#: 305787 batch#: 2087550 it was reported by customer that case is manually created since the manual entry needed based on the daily intake report 29nov2023 (error tracking tab) (email was forwarded to aei on 28nov2023 but aei failed to create the case) verbatim: rcc received a complaint via email.Email(s) attached.Case is manually created since the manual entry needed based on the daily intake report 29nov2023 (error tracking tab) (email was forwarded to aei on 28nov2023 but aei failed to create the case) hsi control number: 118482 hsi description: eclipse syringe w/needle 3cc hsi item number: us_9872945 hsi manufacturer part number: 305787 hsi lot or serial number: (b)(6).The stopper sticks halfway through administering meds; was injecting patients when issue occurred; between 3-5 affected; both female and male; no adverse affects.Failure to deliver.

• Brand Name: BD SYRINGE 3ML LL W/NDL ECLIPSE 25X1
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18536844
• Report Number: 2243072-2024-00033
• Device Sequence Number: 6545222
• Product Code: FMI
• UDI-Device Identifier: 30382903057871
• UDI-Public: (01)30382903057871
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K010188
• 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): 04/18/2024

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: 305787
• Device Lot Number: 2087550
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2023
• Supplement Date Received by Manufacturer: 04/18/2024
• Initial Report FDA Received Date: 01/18/2024
• Supplement Report FDA Received Date: 04/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown