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

Model Number	300255
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 9345481; medical device expiration date: 31-dec-2024; device manufacture date: 14-feb-2020; medical device lot #: 9287104; medical device expiration date: 31-oct-2024; device manufacture date: 09-dec-2019; medical device lot #: 9021603; medical device expiration date: 29-feb-2024; device manufacture date: 08-apr-2019.Investigation summary: the customer issued a complaint for leakage detected during customer usage.No samples were provided to bd medical ¿ pharmaceutical system (bdm-ps) for analysis.1 photo was provided.A droplet of hyaluronic acid can be seen on the joint of the hypoint hub and the syringe.The hypoint needle appears to be not attached correctly to the syringe.The sample is not required for the investigation as it will be contaminated with hyaluronic acid and as such we cannot complete testing as per applicable quality criteria on returned sample.The hypoint needle and hub in the photo appears complete and does not appear damaged.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 met all acceptable quality levels (aql¿s), were manufactured and released according to applicable procedures and specifications.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.Unconfirmed: bd could not confirm the reported condition.
Event or Problem Description
It was reported that 19 bd hypoint¿ needles leaked during the injection.The following information was provided by the initial reporter: the hospital reported that there was leakage during injection, and the filling liquid was sodium hyaluronate.

• 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: 15191155
• Report Number: 8041187-2022-00438
• Device Sequence Number: 5974769
• Product Code: FMI
• UDI-Device Identifier: 00382903002559
• UDI-Public: 00382903002559
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 08/04/2022

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: 02/29/2024
• Device Model Number: 300255
• Device Catalogue Number: 300255
• Device Lot Number: 9021603
• 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: 07/13/2022
• Initial Report FDA Received Date: 08/09/2022
• 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