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

Model Number	300253
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: the customer issued a complaint for a mismatch between the catalogue number on lid label and coc received.One (1) photo was received, one (1) tax invoice for material code 300253 & one (1) coc were provided to bd medical ¿ pharmaceutical system (bdm-ps) for analysis.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.Based on the investigation conclusion, bdm-ps was not able to confirm the symptom perceived by the customer or correlate this symptom with a potential cause linked to bd process.
Event or Problem Description
It was reported that the catalog number of the bd hypoint¿ hypodermic needle was listed as 300253 on the coc, while it was listed as 3002535 on the label.The following information was provided by the initial reporter: "a confirmation is required on the highlighted number mentioned in the image i.E., ¿3002535¿.Is this is the catalogue number or not? if this is the catalogue number, then it is not matching with the requirement of specification and coc (catalogue number in specification and vendor coc is ¿300253¿).".
Event or Problem Description
It was reported that the catalog number of the bd hypoint¿ hypodermic needle was listed as 300253 on the coc, while it was listed as 3002535 on the label.The following information was provided by the initial reporter: "a confirmation is required on the highlighted number mentioned in the image i.E., ¿3002535¿.Is this is the catalogue number or not? if this is the catalogue number, then it is not matching with the requirement of specification and coc (catalogue number in specification and vendor coc is ¿300253¿).".
Additional Manufacturer Narrative
H6: investigation summary the customer issued a complaint for a mismatch between the catalogue number on lid label and coc received.One (1) photo was received, one (1) tax invoice for material code 300253 & one (1) coc were provided to bd medical ¿ pharmaceutical system (bdm-ps) for analysis.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.From the above investigation, the lid label information matches our internal drawing documents and there is no discrepancy between the material number on the coc and the sap system.Bd-ps confirms the number indicated in the lid label udi-di(b)(4) corresponds to the unique device identifier (udi) for hypoint needle 25g x 5/8¿.There is no requirement which mentions that the number printed on the lid label must mention the catalogue number.Based on the investigation conclusion, bdm-ps was not able to confirm the symptom perceived by the customer or correlate this symptom with a potential cause linked to bd process.

• 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
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17015223
• Report Number: 8041187-2023-00234
• Device Sequence Number: 20551181
• Product Code: FMI
• UDI-Device Identifier: 00382903002535
• UDI-Public: 00382903002535
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2023

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: 02/28/2025
• Device Model Number: 300253
• Device Catalogue Number: 300253
• Device Lot Number: 0044266
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2023
• Supplement Date Received by Manufacturer: 06/05/2023
• Initial Report FDA Received Date: 05/26/2023
• Supplement Report FDA Received Date: 06/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown