MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 3ML LL W/NDL SFTYGLD 25X1 RB; PISTON SYRINGE

Model Number	305924
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple medical device types reported to be involved.The information for the additional device type is as follows: common device name: hypodermic single lumen needle.Medical device type: fmi.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 7156653.Medical device expiration date: 2022-05-31.Device manufacture date: 2017-06-05.Medical device lot #: 8064678.Medical device expiration date: 2023-02-28.Device manufacture date: 2018-03-05.Medical device lot #: 6305556.Medical device expiration date: 2021-10-31.Device manufacture date: 2016-10-31.Medical device lot #: 8119703.Medical device expiration date: 2023-04-30.Device manufacture date: 2018-04-29.Medical device lot #: unknown.Medical device expiration date: unknown.Device manufacture date: unknown.Pma/510(k)#: k980987 / k951254.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 has been reported that the bd¿ syringe 3ml ll w/ndl sftygld 25x1 rb has been found experiencing five occurrences of containing foreign matter before use.The following has been provided by the initial reporter: it was reported that fluid/lubricant/substance in the 3 ml bd syringe.Per customer email: there appears to be fluid/lubricant/substance in the 3 ml bd syringe when the nurse opened the package to take the syringe out prior to withdrawing vaccine.This has happened to several syringes noted by this nurse.
Additional Manufacturer Narrative
H.6.Investigation summary: three photos and seven 3ml syringes in opened blister packs (p/n 305924) were received and evaluated.Two were from batch 7156653, two were from batch 7347873, three were from batch 6305556, and one was from 8064678.It was observed in the photo and physical samples the "clear fluid" was silicone and was the normal and expected amount per product specification.The reported defect was not identified in the samples received.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number(s) that could have contributed to the reported defect.H3 other text : see section h.10.
Event or Problem Description
It has been reported that the bd¿ syringe 3ml ll w/ndl sftygld 25x1 rb has been found experiencing five occurrences of containing foreign matter before use.The following has been provided by the initial reporter: it was reported that fluid/lubricant/substance in the 3 ml bd syringe.Per customer email: there appears to be fluid/lubricant/substance in the 3 ml bd syringe when the nurse opened the package to take the syringe out prior to withdrawing vaccine.This has happened to several syringes noted by this nurse.

• Brand Name: BD SYRINGE 3ML LL W/NDL SFTYGLD 25X1 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 9467314
• Report Number: 1213809-2019-01266
• Device Sequence Number: 2139643
• Product Code: FMF
• UDI-Device Identifier: 30382903059240
• UDI-Public: 30382903059240
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 01/14/2020

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: Health Professional
• Device Model Number: 305924
• Device Catalogue Number: 305924
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/28/2019
• Supplement Date Received by Manufacturer: 11/28/2019
• Initial Report FDA Received Date: 12/13/2019
• Supplement Report FDA Received Date: 01/14/2020
• 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