MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD 5ML LL SYRINGE; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305785
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd 5ml ll syringe experienced stopper separation from the plunger.The following information was provided by the initial reporter: distorted stopper.
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 11/5/2021.H.6.Investigation: one photo and one sample were received by our quality team for evaluation.From the photo and the sample, the stopper is separated from the plunger.The plunger of the sample was subjected to visual inspection and short molding was observed at the plunger head.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.The separation between the stopper and plunger is due to short molding at the plunger head.Short molding on the plunger head could have occurred during machine start-up.The initial shots with short molding defect after machine start-up were not effectively purged and removed before conveyed to the subsequent process.The production technicians have been retrained to purge out at least seven shots during machine start-up after this batch was production.H3 other text : see h.10.
Event or Problem Description
It was reported that the bd 5ml ll syringe experienced stopper separation from the plunger.The following information was provided by the initial reporter: distorted stopper.

• Brand Name: BD 5ML LL SYRINGE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12815328
• Report Number: 8041187-2021-00973
• Device Sequence Number: 17337857
• Product Code: FMI
• UDI-Device Identifier: 30382903057857
• UDI-Public: 30382903057857
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K010188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2021

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 Expiration Date: 01/31/2025
• Device Model Number: 305785
• Device Catalogue Number: 305785
• Device Lot Number: 0057551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2021
• Supplement Date Received by Manufacturer: 12/09/2021
• Initial Report FDA Received Date: 11/15/2021
• Supplement Report FDA Received Date: 12/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2020
• 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