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

Catalog Number	300208
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/25/2017
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 consumer received a bd hypoint¿ needle that was not sealed causing them to question the sterility of the needle.The product was not used and there was no report of injury or medical interventions.
Additional Manufacturer Narrative
One sample was received and it was observed that the shield was cracked and had a rough broken edge.A review of the device history record revealed no irregularities during the manufacture of the reported lot numbers.A manufacturing review revealed no abnormalities with preventative maintenance, calibration, or equipment.There is online shield leakage test that will reject the reported non-conformance in hypoint assembly.There is no contact point with the hypoint shield after shield leakage test which will result in the reported non-conformance.Although the customer¿s reported defect was confirmed, an absolute root cause for this incident cannot be determined as the process is capable to reject the reported non-conformance.

• Brand Name: BD HYPOINT¿ NEEDLE
• Common Device Name: HYPODERMIC NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 7035621
• Report Number: 8041187-2017-00175
• Device Sequence Number: 1238388
• Product Code: FMI
• UDI-Device Identifier: 00382903002085
• UDI-Public: 00382903002085
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K070440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2017

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: 02/28/2019
• Device Catalogue Number: 300208
• Device Lot Number: 4043134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2017
• Initial Date Received by Manufacturer: 10/25/2017
• Supplement Date Received by Manufacturer: 10/25/2017
• Initial Report FDA Received Date: 11/15/2017
• Supplement Report FDA Received Date: 12/20/2017
• 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