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

Model Number	300253
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd hypoint¿ hypodermic needle broke in the avonex pen.This occurred once each in lots 1013936 and 1013938.The following information was provided by the initial reporter: "we have received a complaint from our customer regarding that the needle was broken in an avonex pen.According to the patient and the nurse, there was no other piece of needle to be found.".
Additional Manufacturer Narrative
Initial reporter phone#: unknown.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1013936, medical device expiration date: 31-jan-2026, device manufacture date: 16-feb-2021.Medical device lot #: 1013938, medical device expiration date: 31-jan-2026, device manufacture date: 26-feb-2021.Investigation summary: no samples, only 2 photos, 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.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.2 photos were observed to have the needle broken.It was unclear to whether the needle was found broken before, during or after usage, making it inconclusive at which action/stage the needle was broken.Based on the sample analysis 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.Unconfirmed: bd could not confirm the reported condition.Note: this is the classification since we are unable to determine at what stage the damage occurred.

• 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 ; 8015296192
• MDR Report Key: 15563974
• Report Number: 8041187-2022-00580
• Device Sequence Number: 6584935
• Product Code: FMI
• UDI-Device Identifier: 00382903002535
• UDI-Public: (01)00382903002535
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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): 10/05/2022

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: Health Professional
• Device Expiration Date: 01/31/2026
• Device Model Number: 300253
• Device Catalogue Number: 300253
• Device Lot Number: 1013936
• 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: 09/16/2022
• Initial Report FDA Received Date: 10/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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