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	02/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported bd hypoint¿ needle had leakage issues.The following information was provided by the initial reporter: ".The solution dipped into the cap.".
Event or Problem Description
It was reported bd hypoint¿ needle had leakage issues.The following information was provided by the initial reporter: ".The solution dipped into the cap.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for eval? yes.D9: returned to manufacturer on: 20-may-2022 h6: investigation summary sample was received for evaluation 20-may-2022.The returned sample was observed with bent & broken needle.A leak test was completed and no leak was identified.The cause of the broken needle could not be determined from the sample.The existing control plan is capable of removing non conforming parts.Action has already been implemented for bent needle.The affected batch are produced in 04-oct-20 actions implemented in 09-oct-20.Based on the investigation conclusion, bdm-ps was able to confirm the detection and characterize the condition reported by customer.The reported condition has been confirmed to be within the specified acceptable quality level (aql¿s) defined in the applicable specification.As a consequence, bdm-ps will not define corrective actions following the investigation of this complaint.However, this complaint is registered in bd complaint system for future review in subsequent customer complaint investigation.
Event or Problem Description
It was reported bd hypoint¿ needle had leakage issues.The following information was provided by the initial reporter: ".The solution dipped into the cap.".
Additional Manufacturer Narrative
H6: investigation summary: the customer issued a complaint for bent, short needle and leak detected during customer usage.No samples 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.Bent needle was observed from the returned photo.The needle when compared to the hub length appears shorter than expected.This information with that of the customer who states ¿the needle is shorter¿ suggests that the needle is short.Returned photos are unclear to identify a root cause.In relation to ¿solution dipped into the cap¿ we do not understand issue and this cannot be evaluated and no root cause can be assigned.H3 other text : see h10.

• 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: 13690298
• Report Number: 8041187-2022-00110
• Device Sequence Number: 14684965
• Product Code: FMI
• UDI-Device Identifier: 00382903002559
• UDI-Public: 00382903002559
• Combination Product (Y/N): Y
• Initial Reporter Country: AU
• 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,Followup,Followup
• Report Date (Section B): 06/10/2022

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: 08/31/2025
• Device Model Number: 300255
• Device Catalogue Number: 300255
• Device Lot Number: 0227855
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2022
• Supplement Date Received by Manufacturer: 03/18/2022; 06/10/2022
• Initial Report FDA Received Date: 03/08/2022
• Supplement Report FDA Received Date: 04/05/2022; 06/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2020
• 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