MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD ECLIPSE¿ NEEDLE WITH DETACHABLE BD LUER-LOK¿ SYRINGE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305780
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd eclipse¿ needle with detachable bd luer-lok¿ syringe had a broken plunger.The following information was provided by the initial reporter, translated from mandarin chinese to english: broken plunger (pir3031744).
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for evalution?yes.D10: returned to manufacturer on: 26-jan-2023 h6: investigation summary our quality engineer inspected the 3 photos and 5 samples submitted for evaluation.The reported issues of plunger rod broken / damaged were confirmed upon inspection of the samples.One syringe was received in an opened package with the needle missing from batch 2027737.It had a broken plunger rod with the entire thumb rest broken off.One image shows two loose 1ml syringes with the plunger drawn back until the stopper rests at the 0.4ml.The tip of the stopper is not flat on one of the syringes and the other looks acceptable.An image shows a loose syringe with the broken plunger rod missing the thumb rest as previously described in the sample.Potential root cause for the broken plunger rod defect is associated with the assembly process.Production records were reviewed, and this batch meets our manufacturing specification requirements.
Event or Problem Description
It was reported that the bd eclipse¿ needle with detachable bd luer-lok¿ syringe had a broken plunger.The following information was provided by the initial reporter, translated from mandarin chinese to english: broken plunger (pir3031744).

• Brand Name: BD ECLIPSE¿ NEEDLE WITH DETACHABLE BD LUER-LOK¿ 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16261149
• Report Number: 8041187-2023-00026
• Device Sequence Number: 15149929
• Product Code: FMI
• UDI-Device Identifier: 00382903057801
• UDI-Public: 00382903057801
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K941562
• 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): 03/17/2023

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: 305780
• Device Lot Number: 2027737
• 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: 01/05/2023
• Supplement Date Received by Manufacturer: 03/17/2023
• Initial Report FDA Received Date: 01/28/2023
• Supplement Report FDA Received Date: 03/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2022
• 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