MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS 1 ML BD SLIP TIP SYRINGE WITH ATTACHED NEEDLE; PISTON SYRINGE

Catalog Number	309597
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr? 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 that a needle 22x1-1/2 rb i is not injecting full dose, and leaves 0.5ml of product in the syringe.The plunger stopper in the syringe barrel is not flush with the bottom.
Additional Manufacturer Narrative
H.6.Investigation: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.
Event or Problem Description
It was reported that a 1 ml bd slip tip syringe with attached needle is not injecting full dose, and leaves 0.5ml of product in the syringe.The plunger stopper in the syringe barrel is not flush with the bottom.
Additional Manufacturer Narrative
The corrections are as follows: describe event or problem: it was reported that a 1 ml bd slip tip syringe with attached needle is not injecting full dose, and leaves 0.5ml of product in the syringe.The plunger stopper in the syringe barrel is not flush with the bottom.Medical device brand name: 1 ml bd slip tip syringe with attached needle.Medical device type: fmf.Common device name: piston syringe.Medical device manufacturer: mfg us canaan.Medical device catalog #: 309597.Medical device lot #: 8059526.Medical device expiration date: 2023-02-28.Unique identifier (udi) #: 30382903095972.Manufacturing location: mfg us canaan.Pma / 510(k)#: k980987.Device manufacture date: 2018-02-28.
Event or Problem Description
It was reported that a 1 ml bd slip tip syringe with attached needle is not injecting full dose, and leaves 0.5ml of product in the syringe.The plunger stopper in the syringe barrel is not flush with the bottom.

• Brand Name: 1 ML BD SLIP TIP SYRINGE WITH ATTACHED NEEDLE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8351603
• Report Number: 1911916-2019-00194
• Device Sequence Number: 193330
• Product Code: FMF
• UDI-Device Identifier: 30382903051565
• UDI-Public: 30382903051565
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/25/2019

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: Lay User/Patient
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: 309597
• Device Lot Number: 8059526
• Initial Date Received by Manufacturer: 01/28/2019
• Supplement Date Received by Manufacturer: 01/28/2019; 01/28/2019
• Initial Report FDA Received Date: 02/19/2019
• Supplement Report FDA Received Date: 03/06/2019; 04/25/2019
• 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