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

Catalog Number	300255
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 7016301.Medical device expiration date: 2022-01-31.Device manufacture date: 2017-02-23.Medical device lot #: 7016308.Medical device expiration date: 2022-01-31.Device manufacture date: 2017-03-09.(b)(6).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 bd hypoint¿ hypodermic needle leaked due to a molding defect before use.No serious injury or medical intervention was reported.
Event or Problem Description
It was reported that bd hypoint hypodermic needle leaked due to a molding defect before use.No serious injury or medical intervention was reported.
Additional Manufacturer Narrative
Returned photos were received and observed dented at the red arrow marked at the needle.One returned sample was received.The hub was observed to have dented mark.Luer taper inspection was performed and result is passed.Dhr review of hypoint batch 7016301, 7016308 and hypodermic hub batch 7025451 shows no quality notification was raised for this defect.Upon investigation, at the shield removal station, there may be rubbing at the hub with the shield removal plate.The shield removal plate was repaired at the surface due to scratches at the top caused by gripper.This repair allowed the shield removal plate to be able to adjust and reduce interference of the hub with the shield removal plate.This was completed in oct-2018.The production batches were produced on (b)(6) 2017 which is prior to the implementation of the corrective action.No capa is required as corrective action has been implemented.

• Brand Name: BD HYPOINT¿ HYPODERMIC NEEDLE
• Common Device Name: NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8125270
• Report Number: 8041187-2018-00443
• Device Sequence Number: 1770964
• Product Code: FMI
• UDI-Device Identifier: 00382903002559
• UDI-Public: 00382903002559
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K070440
• 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): 12/12/2018

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 Catalogue Number: 300255
• Device Lot Number: SEE H.10
• Initial Date Received by Manufacturer: 11/16/2018
• Supplement Date Received by Manufacturer: 11/16/2018
• Initial Report FDA Received Date: 12/03/2018
• Supplement Report FDA Received Date: 12/12/2018
• 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