MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD HYPOINT¿ NEEDLE

Catalog Number	300263
Health Effect - Clinical Code	Missed Dose (2561)
Date of Event	04/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.Initial reporter phone #: unknown.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 medication is not injected due to difficult plunger with a bd hypoint¿ needle.The following information was provided by the initial reporter: during the preparation of the syringe before the injection, the solution did not comes out when he pushed plunger.
Event or Problem Description
It was reported that medication is not injected due to difficult plunger with a bd hypoint¿ needle.The following information was provided by the initial reporter: during the preparation of the syringe before the injection, the solution did not comes out when he pushed plunger.
Additional Manufacturer Narrative
Investigation: the complaint is unconfirmed as no photo / samples received.Dhr reviewed and no abnormalities were observed that influence clogged needle.Since no samples and photos displaying the reported condition were received the root cause could not be determined.

• Brand Name: BD HYPOINT¿ NEEDLE
• Common Device Name: NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8617838
• Report Number: 8041187-2019-00384
• Device Sequence Number: 2087288
• 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: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2019

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: 06/30/2023
• Device Catalogue Number: 300263
• Device Lot Number: 8196224
• Initial Date Received by Manufacturer: 04/30/2019
• Supplement Date Received by Manufacturer: 04/30/2019
• Initial Report FDA Received Date: 05/16/2019
• Supplement Report FDA Received Date: 05/23/2019
• 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