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

Catalog Number	300263
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/14/2020
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 the hypoint ndl22ga1-1/2in tw was blocked and wouldn't withdraw the contents of the vial during use.The following information was provided by the initial reporter: "regular patient can't withdraw the content from the vial.".
Event or Problem Description
It was reported that the hypoint ndl22ga1-1/2in tw was blocked and wouldn't withdraw the contents of the vial during use.The following information was provided by the initial reporter: "regular patient can't withdraw the content from the vial.".
Additional Manufacturer Narrative
H.6.Investigation: dhr reviewed for the affected batch numbers and did not observe abnormalities.As there is no returned samples and photos for investigation, root cause could not establish.

• 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: 9831801
• Report Number: 8041187-2020-00144
• Device Sequence Number: 19657501
• Product Code: FMI
• UDI-Device Identifier: 00382903002634
• UDI-Public: 00382903002634
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (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): 04/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: 300263
• Device Lot Number: 8338559
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/21/2020
• Supplement Date Received by Manufacturer: 02/21/2020
• Initial Report FDA Received Date: 03/13/2020
• Supplement Report FDA Received Date: 04/03/2020
• 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