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

Model Number	300255
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: the customer issued a complaint for colour of the hypoint shield detected before use.No samples were provided for analysis.Returned photo was provided for analysis.The transparency of the shield is slightly different between the photos.Bd does not have a criteria for the transparency or colour of the shield and the parts in the photo are evaluated as conforming to specification.Bdm-ps performed a batch history record¿s review (bhr) including a review of all data collected during in process and quality inspections.The batches involved in this complaint meet all acceptable quality levels (aql¿s), were manufactured, and released according to applicable procedures and specifications.
Event or Problem Description
It was reported that the bd hypoint¿ hypodermic needle container was discolored.The following information was provided by the initial reporter: "a pharmacist reported an issue regarding recormon pfs 5000iu, h0711h07.The pharmacist found that needle containers of the batch have an appearance defect, the needle containers look slightly yellow than other batches.".

• 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: 12256352
• Report Number: 8041187-2021-00671
• Device Sequence Number: 14361281
• Product Code: FMI
• UDI-Device Identifier: 00382903002559
• UDI-Public: 00382903002559
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K070440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/20/2021

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: Other
• Device Expiration Date: 04/30/2025
• Device Model Number: 300255
• Device Catalogue Number: 300255
• Device Lot Number: 0104329
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2021
• Initial Report FDA Received Date: 07/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1