MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD SYRINGE 3ML LL W/NDL ECLIPSE 22X1 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305788
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
Material no.: 305788.Batch no.: 8302596.It was reported that during use of the bd syringe 3ml ll w/ndl eclipse 22x1 rb the syringe plungers are hard to push.The following information was provided by the initial reporter: the plunger of syringes is hard to push (sticking) its keeps stopping and it needs to push hard.
Additional Manufacturer Narrative
H.6.Investigation summary: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of this incident cannot be determined.H3 other text.
Event or Problem Description
Material no: 305788, batch no: 8302596.It was reported that during use of the bd syringe 3ml ll w/ndl eclipse 22x1 rb the syringe plungers are hard to push.The following information was provided by the initial reporter: the plunger of syringes is hard to push (sticking) its keeps stopping and it needs to push hard.

• Brand Name: BD SYRINGE 3ML LL W/NDL ECLIPSE 22X1 RB
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 9178485
• Report Number: 8041187-2019-00806
• Device Sequence Number: 11318983
• Product Code: FMI
• UDI-Device Identifier: 30382903057888
• UDI-Public: 30382903057888
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: SEE H.10
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2019

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: Other
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 305788
• Device Lot Number: 8302596
• Initial Date Received by Manufacturer: 09/26/2019
• Supplement Date Received by Manufacturer: 09/26/2019
• Initial Report FDA Received Date: 10/11/2019
• Supplement Report FDA Received Date: 11/11/2019
• 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