MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) HYPOINT NDL22GA1-1/2IN TW; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	300263
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2021
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 product leaked from the hypoint ndl22ga1-1/2in tw syringe during use.The following information was provided by the initial reporter: "the reporter claims that he/she could not remove the thick needle from the syringe and the product leaked out from the syringe".
Additional Manufacturer Narrative
H6: investigation summary: the customer issued a complaint for difficult to remove detected during use.No samples were provided to bd medical ¿ pharmaceutical system (bdm-ps) for analysis.Bdm-ps performed a batch history record¿s review (bhr) including a review of all data collected during in process and quality inspections.The batches involved in this complaint met all acceptable quality levels (aql¿s), were manufactured and released according to applicable procedures and specifications.
Event or Problem Description
It was reported that product leaked from the hypoint ndl22ga1-1/2in tw syringe during use.The following information was provided by the initial reporter: "the reporter claims that he/she could not remove the thick needle from the syringe and the product leaked out from the syringe.".

• Brand Name: HYPOINT NDL22GA1-1/2IN TW
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 11603284
• Report Number: 8041187-2021-00238
• Device Sequence Number: 3599663
• Product Code: FMI
• UDI-Device Identifier: 00382903002634
• UDI-Public: 00382903002634
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K070440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2021

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: 10/31/2024
• Device Model Number: 300263
• Device Catalogue Number: 300263
• Device Lot Number: 9287090
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/08/2021
• Supplement Date Received by Manufacturer: 04/20/2021
• Initial Report FDA Received Date: 04/01/2021
• Supplement Report FDA Received Date: 04/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1