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	12/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 7051465.Medical device expiration date: 2022-02-28.Device manufacture date: 2017-03-15.Medical device lot #: 7051476.Medical device expiration date: 2022-02-28.Device manufacture date: 2017-03-15.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 a bd hypoint¿ hypodermic needle was leaking before use.
Event or Problem Description
It was reported that a bd hypoint¿ hypodermic needle was leaking before use.
Additional Manufacturer Narrative
H.6.Investigation summary: dhr- no notification was raised for this defect for the past year.No similar non-conformance was detected during in-process inspection.Preventative maintenance and machine history records were reviewed.No related machine issue found during production.Returned photos do not show leakage or tight shield pull.Returned samples do not observe tight shield pull.The hub rib od and snap fit id from hypoint shield which may influence tight shield pull were measured and the result is passed.For leakage, it occurred between the needle hub and syringe.Luer taper inspection was performed and result is passed.The returned samples were performed measurement on the snap fit id (hypoint shield) and hub rib od(hypodermic hub) which may influence the shield pull force experience.The measurement results are within specification.Shield pull force was performed and force is within specification as per sc30.Conclusion: unconfirmed: bd was not able to duplicate or confirm the customer's indicated failure mode.The functional test and relevant measurements on the product components which may influence shield removal experience were performed and result is passed.A graph was plotted to review the shield pull force produced before and after the affected production batches.There is no abnormal trend for the affected batches and the max shield pull force were controlled under 2.5lbs.For leakage, the luer taper may influenced this non-conformance.Inspection was performed and result is passed.

• 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: 8233344
• Report Number: 8041187-2018-00512
• Device Sequence Number: 11240409
• 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): 01/24/2019

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 Catalogue Number: 300255
• Device Lot Number: SEE H.10.
• Initial Date Received by Manufacturer: 12/20/2018
• Supplement Date Received by Manufacturer: 12/20/2018
• Initial Report FDA Received Date: 01/10/2019
• Supplement Report FDA Received Date: 01/24/2019
• 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