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

Catalog Number	305789
Medical Device Problem Codes	Leak/Splash (1354); Short Fill (1575)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device type: fmi, fmf.(b)(4).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 the syringe 1ml ll w/ndl eclipse 27x1/2 rb experienced product damage/deformation, and scale marking issues.The following information was provided by the initial reporter: distorted barrel.
Event or Problem Description
It was reported that the syringe 1ml ll w/ndl eclipse 27x1/2 rb experienced product damage/deformation, and scale marking issues.The following information was provided by the initial reporter: distorted barrel.
Additional Manufacturer Narrative
Investigation summary: photo evaluation: 2 photos were received for investigation.Unable to observe any damage/distorted barrel from the photo but observed ink smear on the syringe barrel.Sample evaluation: 1 unused actual sample in open packaged was received for investigation.The sample was not decontaminated.The 1 actual sample was subjected to visual inspection for damage syringe.Observed the following from the sample.Missing scale marking and ink smear on the syringe barrel.Damage on syringe barrel and syringe tip.A device history record review showed no non-conformances associated with this issue during the production of this batch.Conclusion: machine logs indicate adjustments were made to the marking assembly during the manufacture of this batch.Potential root cause for the damaged flange and foreign matter defects are associated with the marking process.

• Brand Name: SYRINGE 1ML LL W/NDL ECLIPSE 27X1/2 RB
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE; PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8664442
• Report Number: 8041187-2019-00421
• Device Sequence Number: 14011290
• Product Code: FMI
• 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): 07/11/2019

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: 02/28/2023
• Device Catalogue Number: 305789
• Device Lot Number: 8052070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2019
• Initial Date Received by Manufacturer: 05/14/2019
• Supplement Date Received by Manufacturer: 05/14/2019
• Initial Report FDA Received Date: 06/03/2019
• Supplement Report FDA Received Date: 07/12/2019
• 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