MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD® NEEDLE 1 IN. SINGLE USE, STERILE, 21 G; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305165
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.Date of event is unknown; awareness date has been used for this field.H.3.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® needle 1 in.Single use, sterile, 21 g leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: customer reported that there is a hole at the base of the needle which leaks when preparing the medication.A nurse received some in her glasses, because there was a spurt that was projected when she gave the injection.Additional info received on 04-july-23.1.Was the nurse injured? please describe no harm related to the current incident, as the nurse was wearing glasses, fortunately.She received a jet in her glasses.She was doing an iv drug dilution.2.Was the patient injured? no harm to the patient according to the incident noted.However, a number of people have mentioned leaks in the junction between the syringe and the needle.If little resistance is made, there is no jet coming out, but more leaks.Could create improper medication preparation, incorrect concentration 3.Was there any medical intervention? no medical intervention performed on the patient.4.Could the procedure be corrected using another needle? yes the procedure could be corrected using another needle, but it took 2 needles to get one that did not leak.
Event or Problem Description
It was reported while using bd® needle 1 in.Single use, sterile, 21 g leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: customer reported that there is a hole at the base of the needle which leaks when preparing the medication.A nurse received some in her glasses, because there was a spurt that was projected when she gave the injection.Additional info received on 04-july-23.1.Was the nurse injured? please describe.No harm related to the current incident, as the nurse was wearing glasses, fortunately.She received a jet in her glasses.She was doing an iv drug dilution.2.Was the patient injured? no harm to the patient according to the incident noted.However, a number of people have mentioned leaks in the junction between the syringe and the needle.If little resistance is made, there is no jet coming out, but more leaks.Could create improper medication preparation, incorrect concentration.3.Was there any medical intervention? no medical intervention performed on the patient.4.Could the procedure be corrected using another needle? yes the procedure could be corrected using another needle, but it took 2 needles to get one that did not leak.
Additional Manufacturer Narrative
H6: investigation summary.A device history record review was completed by our quality engineer team for provided material number 305165 and lot number 2228049.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.

• Brand Name: BD® NEEDLE 1 IN. SINGLE USE, STERILE, 21 G
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17421333
• Report Number: 1911916-2023-00518
• Device Sequence Number: 15709629
• Product Code: FMI
• UDI-Device Identifier: 30382903051657
• UDI-Public: (01)30382903051657
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K021475
• 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): 08/16/2023

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: 305165
• Device Lot Number: 2228049
• 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: 07/04/2023
• Supplement Date Received by Manufacturer: 08/16/2023
• Initial Report FDA Received Date: 07/28/2023
• Supplement Report FDA Received Date: 08/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2022
• 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