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

Model Number	300255
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Packaging Problem (3007)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/01/2020
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.(b)(4).
Event or Problem Description
It was reported that the bd hypoint hypodermic needle was found sticking through the box before use.The following information was provided by the initial reporter: ¿a patient's employee purchased (b)(6) units of the product at the pharmacy near his home, which were immediately refrigerated.At the time of taking one of them for patient administration, his wife states that she observed that the needle had pierced the box, and it looked like it was sticking out of the secondary packaging.The product was not used, there was no contact with the patient.¿.
Additional Manufacturer Narrative
H.6.Investigation: there is no returned samples and photos for investigation.Hence, unable to confirm the customer experience.Dhr reviewed for affected batch number and observed no abnormalities.Root cause could not be determined.
Event or Problem Description
It was reported that the bd hypoint¿ hypodermic needle was found sticking through the box before use.The following information was provided by the initial reporter: ¿a patient's employee purchased 3 units of the product at the pharmacy near his home, which were immediately refrigerated.At the time of taking one of them for patient administration, his wife states that she observed that the needle had pierced the box, and it looked like it was sticking out of the secondary packaging.The product was not used, there was no contact with the patient.¿.

• Brand Name: BD HYPOINT HYPODERMIC NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 10330213
• Report Number: 8041187-2020-00436
• Device Sequence Number: 19432650
• Product Code: FMI
• UDI-Device Identifier: 00382903002559
• UDI-Public: 00382903002559
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: NA
• 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): 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/31/2024
• Device Model Number: 300255
• Device Catalogue Number: 300255
• Device Lot Number: 9072973
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/06/2020
• Supplement Date Received by Manufacturer: 07/06/2020
• Initial Report FDA Received Date: 07/27/2020
• Supplement Report FDA Received Date: 08/19/2020
• 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