MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) HYPOINT NDL27GA1/2IN; NEEDLE

Model Number	300255
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/04/2020
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.(b)(4).
Event or Problem Description
It was reported that the hypoint ndl27ga1/2in experienced a loose needle.The following information was provided by the initial reporter: distributor has received a complaint from the end user reporting issue the product neorecormon stating the following: ¿needle is very loose and detaches itself from the syringe when the cap is removed.¿.
Additional Manufacturer Narrative
H6: investigation summary: the customer issued a complaint for a very loose needle and that detaches itself from the syringe when the cap is removed.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.Based on the investigation conclusion, bdm-ps was not able to confirm the detection of the symptom perceived by the customer or correlate this symptom with a potential cause linked to bdm-ps process.As a consequence, bdm-ps does not propose any corrective action in the scope of this complaint.H3 other text : see h.10.
Event or Problem Description
It was reported that the hypoint ndl27ga1/2in experienced a loose needle.The following information was provided by the initial reporter: distributor has received a complaint from the end user reporting issue the product neorecormon stating stating the following: ¿needle is very loose and detaches itself from the syringe when the cap is removed.¿.

• Brand Name: HYPOINT NDL27GA1/2IN
• Common Device Name: NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 10962356
• Report Number: 8041187-2020-00809
• Device Sequence Number: 702439
• Product Code: FMI
• UDI-Device Identifier: 00382903002559
• UDI-Public: 00382903002559
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2021

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: 06/30/2024
• Device Model Number: 300255
• Device Catalogue Number: 300255
• Device Lot Number: 9155564
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/11/2020
• Supplement Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 12/07/2020
• Supplement Report FDA Received Date: 01/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1