MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 3ML LL W/NDL SFTYGLD 25X5/8 RB; PISTON SYRINGE

Model Number	305904
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/04/2020
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.
Event or Problem Description
It was reported that syringe 3ml ll w/ndl sftygld 25x5/8 rb package was not sealed.This occurred on 3 occasions before use.The following information was provided by the initial reporter: it was reported there was a silver strip on the back of the package and the package was not sealed at the location of the strip.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10 device available for eval yes, returned to manufacturer on: 2020-06-01.H.6.Investigation summary : three mostly sealed 3ml safetyglide combo blister packs from batch 7302908 (p/n 305904) were received and evaluated.It was observed all three packages contained metallic splice tape on the topside of the top web and black splice tape on the underside of the top web.The black splice tape appeared to prevent a proper seal, which was rejectable per product specification.It was also observed the graphics on the package were offset and not centered.Machine logs indicate there was a top web change then an alignment issue during the manufacture of this batch.A potential root cause for the open seal defect is associated with an equipment failure.It is possible during a top web change, the sensor was inadvertently knocked out of adjustment resulting in the splice tape not being detected.The splice tape sensor and rejection sequence were verified to be working properly as of 6/11/2020.An additional splice tape detection mechanism has been added to this machine as of 5/29/2018.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h.10.
Event or Problem Description
It was reported that syringe 3ml ll w/ndl sftygld 25x5/8 rb package was not sealed.This occurred on 3 occasions before use.The following information was provided by the initial reporter: it was reported there was a silver strip on the back of the package and the package was not sealed at the location of the strip.

• Brand Name: SYRINGE 3ML LL W/NDL SFTYGLD 25X5/8 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 10094272
• Report Number: 1213809-2020-00337
• Device Sequence Number: 2680782
• Product Code: FMF
• UDI-Device Identifier: 30382903059042
• UDI-Public: 30382903059042
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K980987
• 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): 06/19/2020

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: Other
• Device Expiration Date: 10/31/2022
• Device Model Number: 305904
• Device Catalogue Number: 305904
• Device Lot Number: 7302908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2020
• Initial Date Received by Manufacturer: 05/07/2020
• Supplement Date Received by Manufacturer: 05/07/2020
• Initial Report FDA Received Date: 05/27/2020
• Supplement Report FDA Received Date: 06/19/2020
• 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