MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 3ML LL W/NDL SFTYGLD 23X1 RB; PISTON SYRINGE

Model Number	305905
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that a syringe 3ml ll w/ndl sftygld 23x1 rb had a loose stopper: "the rubber plug of the needle core slips off.".
Event or Problem Description
It was reported that a syringe 3ml ll w/ndl sftygld 23x1 rb had a loose stopper: "the rubber plug of the needle core slips off".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-02-01.H6: investigation summary: two photos and one 3ml syringe with attached safetyglide needle (p/n 305905) were received.The sample and photos were visually evaluated.When the plunger rod of the syringe was pulled it separated inside the barrel from the stopper.Further examination of the plunger rod revealed that the head was not formed all the way resulting in a square shape which is rejectable per product specification.Potential root cause for the short shot defect is associated with the molding process.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.H3 other text : see h10.
Additional Manufacturer Narrative
H.6.Investigation: two photos were received and evaluated.One photo displayed a single safetyglide combo blister pack from batch 0136219 (p/n 305905).One photo displayed a loose 3ml syringe with safetyglide needle attached.It was observed in the photo with the syringe, the stopper was in the bottom of the barrel and separated from the plunger rod that was fully extended.It appeared the retraining ring on the plunger rod was not completely formed, which was rejectable per product specification.Potential root cause for the short shot defect is associated with the molding process.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 syringe 3ml ll w/ndl sftygld 23x1 rb had a loose stopper: "the rubber plug of the needle core slips off".

• Brand Name: SYRINGE 3ML LL W/NDL SFTYGLD 23X1 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 11275416
• Report Number: 1213809-2021-00055
• Device Sequence Number: 4960323
• Product Code: MEG
• UDI-Device Identifier: 30382903059059
• UDI-Public: 30382903059059
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K992734
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/15/2021

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: Health Professional
• Device Expiration Date: 04/30/2025
• Device Model Number: 305905
• Device Catalogue Number: 305905
• Device Lot Number: 0136219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2021
• Initial Date Received by Manufacturer: 01/11/2021
• Supplement Date Received by Manufacturer: 02/11/2021; 06/15/2021
• Initial Report FDA Received Date: 02/03/2021
• Supplement Report FDA Received Date: 02/17/2021; 06/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1