MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 3ML LL W/NDL SFTYGLD 23X1 RB; SEE H.10

Model Number	305905
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple medical device types reported to be involved.The information for the additional device type is as follows: medical device type: fmf & fmi, common device name: piston syringe, hypodermic single lumen needle, pma / 510(k)#: k980987(syringe); k951254 (needle).Medical device expiration date: unknown.A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
Event or Problem Description
It was reported that packaging information was missing with a bd syringe 3ml ll w/ndl sftygld 23x1 rb.This occurred on 7 separate occasions prior to use.The following information was provided by the initial reporter, translated from (b)(6) to english: blank packaging.
Additional Manufacturer Narrative
H.6.Investigation: five 3ml syringes with safetyglide needle assemblies were received and evaluated.Four were in fully sealed blister packs and one was loose with the needle assembly attached.It was observed on the four packages, there was a very thin strip of package print present with no legible information.All the packages were from cavity 11 and rejectable per product specification.Additional information was requested and was stated as unavailable.Without any batch information, only a limited investigation could be performed as the date of manufacture is unknown.Dhr could not be performed.Potential root cause for the missing label content defect is associated with the packaging process.It was most likely due to an issue with the top web print head not printing properly.Controls in place include hourly inspections of each of the 20 cavities for packaging related defects.There is also a vision system in place that checks the udi barcode legibility on the packages.Batch information is necessary for a corrective action determination.No corrective actions can be performed currently as the equipment and condition of the machine is unknown during the time of the defect.H3 other text : see h.10.
Event or Problem Description
It was reported that packaging information was missing with a bd syringe 3ml ll w/ndl sftygld 23x1 rb.This occurred on 7 separate occasions prior to use.The following information was provided by the initial reporter, translated from chinese to english: blank packaging.

• Brand Name: BD SYRINGE 3ML LL W/NDL SFTYGLD 23X1 RB
• Common Device Name: SEE H.10
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 10111901
• Report Number: 1213809-2020-00357
• Device Sequence Number: 2379505
• Product Code: FMF
• UDI-Device Identifier: 30382903059059
• UDI-Public: 30382903059059
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: SEE H.10
• 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): 06/25/2020

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 Model Number: 305905
• Device Catalogue Number: 305905
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2020
• Initial Date Received by Manufacturer: 05/13/2020
• Supplement Date Received by Manufacturer: 05/13/2020
• Initial Report FDA Received Date: 06/02/2020
• Supplement Report FDA Received Date: 06/25/2020
• 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