MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 1ML ST BULK CONVENIENCE PAK; PISTON SYRINGE

Catalog Number	309701
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	04/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: 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 foreign matter was found before use with syringes 1ml st bulk convenience pak.The following information was provided by the initial reporter, material no.309701, batch no.8274580.It was reported that there was issues with the 1 ml bd syringes slip tip tray.Six were found with different types of contaminants, four had missing plungers, and one was found with a scale marking issue.Per response email: a foreign brownish spot was seen around the tip of 1ml syringe.This was noticed upon opening the syringe tray prior to using for filling per email: i am the quality assurance specialist.We have discovered fourteen issues from the last six months of this year.Please accept this email as my official notification of our observations and i am requesting bd to conduct an investigation and if applicable implement a capa into the observations.Six empty 1ml bd syringe -slip tip tray were found with different types of contaminants four empty 1ml bd syringe -slip tip in tray were found without plungers in the syringes barrel.One empty 3ml bd syringe -luer lock in tray was found with some type of contaminant.One empty 1ml bd syringe -slip in tip tray was found with a graduated marking defect.One blunt fill needle with filter was found with some kind of defect.I have completed my internal investigation, all of the aforementioned issues were detected by a sterile laboratory assistant upon opening the respective trays in our cleanroom therefore the issues did not originate from our facility.Please note that all of the issues were detected prior to filling products into them so no patient safety was affected.I will also like to inform you that i conducted aql on the remaining empty stock at the time of the observations on the respective bd lots but did not find additional issues ,but the accumulative quantities of defects exceeded our actionable limit hence my request of an investigation.I have the samples of the syringes at my office to aid your investigation, please provide me an instruction and shipping information so i can mail the samples to your quality department.I have also attached a picture of syringes and the needle as evidence of the complaint but you wont be able to see the details of the issues from the picture.Thanks and i look forward to your response soon." multiple complaints have been opened to address the issues described above.This is 1 of 8 complaints.2 occurrences were reported before use.
Additional Manufacturer Narrative
H.6.Investigation: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident, therefore a root cause could not be determined.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.
Event or Problem Description
It was reported that foreign matter was found before use with syringes 1ml st bulk convenience pak.The following information was provided by the initial reporter, material no.309701, batch no.8274580.It was reported that there was issues with the 1 ml bd syringes slip tip tray.Six were found with different types of contaminants, four had missing plungers, and one was found with a scale marking issue.Per response email: a foreign brownish spot was seen around the tip of 1mlsyringe.This was noticed upon opening the syringe tray prior to using for filling.Per email: i am the quality assurance specialist.We have discovered fourteen issues from the last six months of this year.Please accept this email as my official notification of our observations and i am requesting bd to conduct an investigation and if applicable implement a capa into the observations.Six empty 1ml bd syringe -slip tip tray were found with different types of contaminants four empty 1ml bd syringe -slip tip in tray were found without plungers in the syringes barrel.One empty 3ml bd syringe -luer lock in tray was found with some type of contaminant one empty 1ml bd syringe -slip in tip tray was found with a graduated marking defect.One blunt fill needle with filter was found with some kind of defect.I have completed my internal investigation, all of the aforementioned issues were detected by a sterile laboratory assistant upon opening the respective trays in our cleanroom therefore the issues did not originate from our facility.Please note that all of the issues were detected prior to filling products into them so no patient safety was affected.I will also like to inform you that i conducted aql on the remaining empty stock at the time of the observations on the respective bd lots but did not find additional issues ,but the accumulative quantities of defects exceeded our actionable limit hence my request of an investigation.I have the samples of the syringes at my office to aid your investigation, please provide me an instruction and shipping information so i can mail the samples to your quality department.I have also attached a picture of syringes and the needle as evidence of the complaint but you wont be able to see the details of the issues from the picture.Thanks and i look forward to your response soon." multiple complaints have been opened to address the issues described above.This is 1 of 8 complaints.2 occurrences were reported before use.

• Brand Name: SYRINGE 1ML ST BULK CONVENIENCE PAK
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8735769
• Report Number: 1213809-2019-00662
• Device Sequence Number: 19474512
• Product Code: FMF
• UDI-Device Identifier: 30382903097013
• UDI-Public: 30382903097013
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K980580
• 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): 08/08/2019

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: 09/30/2023
• Device Catalogue Number: 309701
• Device Lot Number: 8274580
• Initial Date Received by Manufacturer: 06/10/2019
• Supplement Date Received by Manufacturer: 06/10/2019
• Initial Report FDA Received Date: 06/26/2019
• Supplement Report FDA Received Date: 08/08/2019
• 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