MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) SYRINGE 1ML LL W/NDL ECLIPSE 27X1/2 RB; PISTON SYRINGE

Model Number	305789
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/16/2020
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.
Event or Problem Description
It was reported that 2 syringes 1ml ll w/ndl eclipse 27x1/2 rb experienced difficult plunger movement and product damage/deformation -device still operable.The product defects were noted prior to use.The following information was provided by the initial reporter: syringe can¿t use normally.Plunger rebounded when pull out.
Event or Problem Description
It was reported that 2 syringes 1ml ll w/ndl eclipse 27x1/2 rb experienced difficult plunger movement and product damage/deformation -device still operable.The product defects were noted prior to use.The following information was provided by the initial reporter: syringe can¿t use normally.Plunger rebounded when pull out.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 4/14/2020.H.6.Investigation: one video and two samples were received by our quality team for evaluation.From the video it was observed that the plunger rebounded when withdrawn.The two samples were subjected to inspection by withdrawing the plunger and observed the plunger start to rebound.The eclipse needle product was removed.The plunger was then withdrawn but did not observe the plunger rebound.Another eclipse needle product was attached to the syringes and also did not observed the plunger rebound.The eclipse needle product was subjected to inspection to check for clog.No clog was observed.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.The affected batch had already reached its expiration date of sep-2018.The affected product was detected before usage during stock clearance.Observed plunger rebound when the syringe is attached to the eclipse needle product.Further evaluation on the eclipse needle found no clogged needle.Also, with only the syringe product alone, the plunger was withdraw but did not observed the plunger rebound.Therefore, root cause could not be established.H3 other text : see h.10.

• Brand Name: SYRINGE 1ML LL W/NDL ECLIPSE 27X1/2 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 9928951
• Report Number: 8041187-2020-00195
• Device Sequence Number: 14159955
• Product Code: FMF
• UDI-Device Identifier: 30382903057895
• UDI-Public: 30382903057895
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K941562
• 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): 05/11/2020

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: 09/30/2018
• Device Model Number: 305789
• Device Catalogue Number: 305789
• Device Lot Number: 3260071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2020
• Initial Date Received by Manufacturer: 03/16/2020
• Supplement Date Received by Manufacturer: 03/16/2020
• Initial Report FDA Received Date: 04/06/2020
• Supplement Report FDA Received Date: 05/12/2020
• 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