MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD SYRINGE 3ML LL W/NDL ECLIPSE 25X5/8 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305781
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	07/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical device expiration date: unknown.Initial reporter phone #: unknown.Pma / 510(k)#: k980987(syringe); k161170 (needle).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that caps are not staying on needle and heath care workers are receiving needle stick injuries with a bd syringe 3ml ll w/ndl eclipse 25x5/8 rb.The following information was provided by the initial reporter: (1 of 3).It was reported that the needle caps are not staying on securely resulting in needle sticks to staff.Additional information from reporter: i have had multiple sticks to staff members because the needle caps do not stay on securely.The packages is also more fragile.When ripping the needles from the perforated lines we tend to open the actual package and have to discard the then exposed/non sterile needle.This has been going on for a few months but with more sticks and conversations with staff members (medical assistants and nurses) i have been made aware this is a pretty consistent thing.
Additional Manufacturer Narrative
Investigation: since no samples or photos displaying the condition reported are available for examination, we were unable to fully investigate this incident and a root cause could not be determined.A device history review could also not be completed as no batch number was provided.
Event or Problem Description
It was reported that caps are not staying on needle and heath care workers are receiving needle stick injuries with a bd syringe 3ml ll w/ndl eclipse 25x5/8 rb.The following information was provided by the initial reporter: (1 of 3) it was reported that the needle caps are not staying on securely resulting in needle sticks to staff.Additional information from reporter: i have had multiple sticks to staff members because the needle caps do not stay on securely.The packages is also more fragile.When ripping the needles from the perforated lines we tend to open the actual package and have to discard the then exposed/non sterile needle.This has been going on for a few months but with more sticks and conversations with staff members (medical assistants and nurses) i have been made aware this is a pretty consistent thing.

• Brand Name: BD SYRINGE 3ML LL W/NDL ECLIPSE 25X5/8 RB
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8900773
• Report Number: 8041187-2019-00648
• Device Sequence Number: 242604
• Product Code: FMI
• UDI-Device Identifier: 00382903057818
• UDI-Public: 00382903057818
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: SEE H.10
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 305781
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 07/29/2019
• Supplement Date Received by Manufacturer: 07/29/2019
• Initial Report FDA Received Date: 08/16/2019
• Supplement Report FDA Received Date: 08/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other