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

Model Number	300263
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: investigation summary: the customer issued a complaint for 2 issues: difficulties to open the blister of the needle and screwing on the needle.No sample or photo was provided to bd medical ¿ pharmaceutical system (bdm-ps) for analysis.According to customer verbatim, bd understands that the end-user had difficulties when opening the lid label (open the blister of the needle) and screwing on the needle.Bdm-ps was not able to confirm the condition reported by the customer as no evidence was provided.A review of the quality history within the sap system has been performed as part of the investigation.No quality notifications were identified during the production which relate to the reported condition.The batch was manufactured and released according to applicable procedures and specifications.Consequently, bdm-ps will not define corrective or preventive actions following the investigation of this complaint.This complaint is registered in bd complaint system and trend analysis will be performed.Unconfirmed: no evidence provided h3: see h.10.
Event or Problem Description
It was reported while using bd hypoint¿ needle the needle and syringe were difficult to connect and leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: we inform you that we have received a new complaint for a needle quality problem (¿patient reported difficulties to open the blister of the needle.He also indicated that he had difficulties when screwing on the needle, the liquid spilled out.¿).Batch of 22g needles (hypoint ndl 22ga1-1/2in tw) impacted: 210200238 (supplier batch 0104324); this is the 3rd complaint affecting this batch of needles.
Additional Manufacturer Narrative
H6: investigation summary: no sample or photo was provided to bd medical ¿ pharmaceutical system (bdm-ps) for analysis.According to customer verbatim, bd understands that the end-user had difficulties when opening the lid label (open the blister of the needle) and screwing on the needle.Bdm-ps was not able to confirm the condition reported by the customer as no evidence was provided.The batch involved in this complaint meets all acceptable quality levels (aql¿s), was manufactured, and released according to applicable procedures and specifications.A review of the quality history within the sap system has been performed as part of the investigation.No quality notifications were identified during the production which relate to the reported condition.As this is a market event, the reported condition detected is not part of a sampling plan that allows to conclude about the whole batch, therefore the aql is not applicable.
Event or Problem Description
It was reported while using bd hypoint¿ needle the needle and syringe were difficult to connect and leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: we inform you that we have received a new complaint for a needle quality problem (¿patient reported difficulties to open the blister of the needle.He also indicated that he had difficulties when screwing on the needle, the liquid spilled out.¿).Batch of 22g needles (hypoint ndl 22ga1-1/2in tw) impacted: 210200238 (supplier batch 0104324); this is the 3rd complaint affecting this batch of needles.

• Brand Name: BD HYPOINT¿ 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: 16967678
• Report Number: 8041187-2023-00223
• Device Sequence Number: 17515865
• Product Code: FMI
• UDI-Device Identifier: 00382903002634
• UDI-Public: 00382903002634
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2023

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: 04/30/2025
• Device Model Number: 300263
• Device Catalogue Number: 300263
• Device Lot Number: 0104324
• 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: 04/27/2023
• Supplement Date Received by Manufacturer: 07/06/2023
• Initial Report FDA Received Date: 05/19/2023
• Supplement Report FDA Received Date: 07/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2020
• 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