MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SAFETYGLIDE¿ INSULIN SYRINGE WITH ATTACHED NEEDLE; PISTON SYRINGE

Model Number	305903
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2021
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: common device name: hypodermic single lumen needle.Medical device type: fmi.There were multiple pma / 510(k)#s reported to be involved.The information for each 510(k) number is as follows: pma / 510(k)#: k980580 (syringe).Pma / 510(k)#: k951254 (needle).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 black foreign matter was found on the bd safetyglide¿ insulin syringe with attached needle.The following information was provided by the initial reporter, translated from (b)(6) to english: "opened the package and found that there are black impurities on the needle".
Event or Problem Description
It was reported that black foreign matter was found on the bd safetyglide¿ insulin syringe with attached needle.The following information was provided by the initial reporter, translated from chinese to english: "opened the package and found that there are black impurities on the needle".
Additional Manufacturer Narrative
Investigation summary: two photos and one 1ml syringe (p/n 305903) in a partially opened blisterpak from batch # 0325431 was received at bd vernon hills.Sample was used for fourier transform infrared spectroscopy (ftir) analysis, extra photo has been taken and sent to bd canaan for evaluation.Three photos displaying 1ml safetyglide combo product with 25gx5/8 needle (p/n 305903) from batch #0325431 were received and evaluated.One photo showed the graphic side of the blisterpak.Two photos showed the needle which had a pile of loose black particulate foreign matter inside of the needle hub.Fourier transform infrared spectroscopy (ftir) analysis of the foreign matter revealed the foreign matter to most likely be made of polyetherimide.The needle observed was non-conforming per product specification.Potential root cause for loose foreign matter defect is associated with the needle supplier¿s manufacturing process.This material is not used in the packaging of the needle.Photos were sent to needle supplier¿s manufacturing site for further investigation.Further investigation performed at needle manufacturing site.Based on the investigation and with the photo sample analysis the symptom reported by the customer is confirmed.We will continue monitoring the complaint trend for the product and symptom.Probable root cause is unknown.The fourier transform infrared spectroscopy (ftir) spectra shows the polyetherimide match with a 58.99 % which is low and considered inconclusive.The mentioned material is not used in the manufacturing process.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.H3 other text : see h10.

• Brand Name: BD SAFETYGLIDE¿ INSULIN SYRINGE WITH ATTACHED NEEDLE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12619207
• Report Number: 1213809-2021-00710
• Device Sequence Number: 1336965
• Product Code: FMF
• UDI-Device Identifier: 30382903059035
• UDI-Public: 30382903059035
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K951254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2021

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: 11/30/2025
• Device Model Number: 305903
• Device Catalogue Number: 305903
• Device Lot Number: 0325431
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2021
• Supplement Date Received by Manufacturer: 12/13/2021
• Initial Report FDA Received Date: 10/12/2021
• Supplement Report FDA Received Date: 01/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown