MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD ECLIPSE¿ NEEDLE 25 G X 1 1/2 IN. SINGLE USE STERILE; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305767
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event is unknown; awareness date has been used for this field.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd eclipse¿ needle 25 g x 1 1/2 in.Single use sterile a needle was found to be clogged.There were 5 instances of this.There was no report of patient impact.The following information was provided by the initial reporter: material no.: 305767.Batch no.: 1028656.It was reported that staff is unable to push medication out of the needle.Recently had several issues (approx.5) reported.Staff are able to extract the med, then push to displaced any air but once injected into the patient, staff are unable to push any farther causing multiple needle sticks where otherwise only one would be needed.Staff have changed out the needle and have then been able to push the drug.
Additional Manufacturer Narrative
Date of event is unknown; awareness date has been used for this field.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd eclipse¿ needle 25 g x 1 1/2 in.Single use sterile a needle was found to be clogged.There were 5 instances of this.There was no report of patient impact.The following information was provided by the initial reporter: material no.: 305767.Batch no.: 1028656.It was reported that staff is unable to push medication out of the needle.Recently had several issues (approx.(b)(4)) reported.Staff are able to extract the med, then push to displaced any air but once injected into the patient, staff are unable to push any farther causing multiple needle sticks where otherwise only one would be needed.Staff have changed out the needle and have then been able to push the drug.
Additional Manufacturer Narrative
H.6.Investigation: one photo was received by our quality team for evaluation.From the photo, a clogged needle defect was not able to be observed as only the top web was shown.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.Based on the quality team's investigation, the root cause of this incident cannot be determined.
Event or Problem Description
It was reported while using bd eclipse¿ needle 25 g x 1 1/2 in.Single use sterile a needle was found to be clogged.There were 5 instances of this.There was no report of patient impact.The following information was provided by the initial reporter: material no.: 305767.Batch no.: 1028656.It was reported that staff is unable to push medication out of the needle.Recently had several issues (approx.5) reported.Staff are able to extract the med, then push to displaced any air but once injected into the patient, staff are unable to push any farther causing multiple needle sticks where otherwise only one would be needed.Staff have changed out the needle and have then been able to push the drug.

• Brand Name: BD ECLIPSE¿ NEEDLE 25 G X 1 1/2 IN. SINGLE USE STERILE
• 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: 13333814
• Report Number: 8041187-2022-00027
• Device Sequence Number: 4885378
• Product Code: FMI
• UDI-Device Identifier: 30382903057673
• UDI-Public: 30382903057673
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K161170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2022

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: 01/31/2026
• Device Model Number: 305767
• Device Catalogue Number: 305767
• Device Lot Number: 1028656
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2021
• Supplement Date Received by Manufacturer: 01/26/2022
• Initial Report FDA Received Date: 01/24/2022
• Supplement Report FDA Received Date: 02/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2021
• 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