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

Model Number	300263
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd hypoint¿ needle was blocked and solution couldn't be drawn into the syringe.The following information was provided by the initial reporter, translated from french: "reporter stated that they were not able to draw up the solution into the syringe".
Additional Manufacturer Narrative
Investigation summary: the customer issued a complaint for clogged cannula detected during use by end customer.No sample or photo was provided to bd medical ¿ pharmaceutical system (bdm-ps) for analysis.Based on the description bd assigned a quality criteria that is related to the reported condition and identified in the agreed specification.After reviewing the occurrence, irrespective of root cause, it is within the specification and no further action will be assigned.The report will not be updated if the sample is received after the approval of this report.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.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.As no sample was provided to bdm-ps for analysis and no additional information is available, the 8d team leader is not able to delve deeper into the investigation and correlate this symptom with a potential cause linked to bdm-ps hypoint manufacturing process.Unconfirmed: no evidence provided.

• 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 ; 8015296192
• MDR Report Key: 15474318
• Report Number: 8041187-2022-00554
• Device Sequence Number: 2873567
• Product Code: FMI
• UDI-Device Identifier: 00382903002634
• UDI-Public: (01)00382903002634
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other,Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2022

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: 07/31/2026
• Device Model Number: 300263
• Device Catalogue Number: 300263
• Device Lot Number: 1188440
• 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: 08/30/2022
• Initial Report FDA Received Date: 09/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2021
• 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