MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD LUER-LOK¿ SYRINGE WITH BD ECLIPSE¿ SAFETY; PISTON SYRINGE

Catalog Number	305785
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd luer-lok¿ syringe with bd eclipse¿ safety the device was damaged.There was no report of patient impact.The following information was provided by the initial reporter: broken barrel.
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 26-jan-2023.H6: investigation summary: our quality engineer inspected the 1 photo and 1 sample submitted for evaluation.The reported issue of barrel / flange damaged was confirmed upon inspection of the sample.Analysis of the sample showed that the barrel and flange were broken.The defect is caused by jam at the reject station due to stopper position high rejects.The high rejects were due to inconsistent stopper position during the plunger insertion.An action was taken to replace with level rollers which will ensure a more even and consistent plunger insertion and stopper position and thus result in less jams and rejects at the stopper position reject station.This batch was produced before the action took place.Production records were reviewed, and this batch meets our manufacturing specification requirements.H3 other text : see h10.
Event or Problem Description
It was reported while using bd luer-lok¿ syringe with bd eclipse¿ safety the device was damaged.There was no report of patient impact.The following information was provided by the initial reporter: broken barrel.

• Brand Name: BD LUER-LOK¿ SYRINGE WITH BD ECLIPSE¿ SAFETY
• Common Device Name: PISTON SYRINGE
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16250996
• Report Number: 8041187-2023-00021
• Device Sequence Number: 17515499
• Product Code: FMF
• UDI-Device Identifier: 00382903057856
• UDI-Public: 00382903057856
• 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): 03/02/2023

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 Catalogue Number: 305785
• Device Lot Number: 1361158
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2023
• Supplement Date Received by Manufacturer: 03/02/2023
• Initial Report FDA Received Date: 01/26/2023
• Supplement Report FDA Received Date: 03/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/27/2021
• 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