MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD HYPOINT; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number 300253

Device Problem Leak/Splash (1354)

Patient Problem Underdose (2542)

Event Date 04/11/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that leakage occurred during use with a bd hypoint.The following information was provided by the initial reporter, "the patient reported they have been using medication for over a year and they never had this issue before.The patient stated the syringe leaked and that there was fluid coming out where needle attaches to the syringe.Patient only received a partial dose.".

Manufacturer Narrative

Investigation summary: no sample or photo returned.A review of the device history record revealed no irregularities during the manufacture of the reported lot.The root cause could not be established as there are no returned samples or photos for investigation.

Event Description

It was reported that leakage occurred during use with a bd hypoint.The following information was provided by the initial reporter, ""the patient reported they have been using medication for over a year and they never had this issue before.The patient stated the syringe leaked and that there was fluid coming out where needle attaches to the syringe.Patient only received a partial dose.".

• Brand Name: BD HYPOINT
• Type of Device: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8898988
• MDR Text Key: 155978913
• Report Number: 8041187-2019-00643
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 00382903002535
• UDI-Public: 00382903002535
• Combination Product (y/n): N
• PMA/PMN Number: K070440
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: 300253
• Device Lot Number: 7257350
• Date Manufacturer Received: 07/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other