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 Consequences Or Impact To Patient (2199)
Date of Event	06/01/2020
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.(b)(4).
Event or Problem Description
It was reported that hypoint ndl22ga1-1/2in tw leaked during use.The following information was provided by the initial reporter: we inform you that we have received a new complaint for a needle quality issue ¿patient stated after reconstitution during drew the solution into syringe, the solution was leaking¿.
Additional Manufacturer Narrative
Correction: complaint is being cancelled.Customer stated that leakage was on the syringe and no on the needle.
Event or Problem Description
It was reported that hypoint ndl22ga1-1/2in tw leaked during use.The following information was provided by the initial reporter: we inform you that we have received a new complaint for a needle quality issue ¿patient stated after reconstitution during drew the solution into syringe, the solution was leaking¿.

• 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: 10172165
• Report Number: 8041187-2020-00349
• Device Sequence Number: 908431
• Product Code: FMI
• UDI-Device Identifier: 00382903002634
• UDI-Public: 00382903002634
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (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): 06/22/2020

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: 12/31/2023
• Device Model Number: 300263
• Device Catalogue Number: 300263
• Device Lot Number: 8338559
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/01/2020
• Supplement Date Received by Manufacturer: 06/01/2020
• Initial Report FDA Received Date: 06/18/2020
• Supplement Report FDA Received Date: 06/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other