MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) HYPOINT NDL22GA1-1/2IN TW; 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	03/24/2021
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that hypoint ndl22ga1-1/2in tw leaked.The following information was provided by the initial reporter: ¿when performing the dilution of the product, noticed that the needle thread was loose, as there was leakage and consequent loss of medicament¿.
Additional Manufacturer Narrative
H.6.Investigation: based on dhr review, there is no abnormality that may influenced this non-conformance.There is no returned samples or photos for investigation.Hence, no root cause is established.The complaint could not be confirmed h3 other text : see h.10.
Event or Problem Description
It was reported that hypoint ndl22ga1-1/2in tw leaked.The following information was provided by the initial reporter: when performing the dilution of the product, noticed that the needle thread was loose, as there was leakage and consequent loss of medicament.

• Brand Name: HYPOINT NDL22GA1-1/2IN TW
• Common Device Name: NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 11704407
• Report Number: 8041187-2021-00335
• Device Sequence Number: 14317941
• Product Code: FMI
• UDI-Device Identifier: 00382903002634
• UDI-Public: 00382903002634
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2021

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: Lay User/Patient
• 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: 03/25/2021
• Supplement Date Received by Manufacturer: 05/26/2021
• Initial Report FDA Received Date: 04/21/2021
• Supplement Report FDA Received Date: 06/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1