MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS 1 ML BD SAFETYGLIDE INSULIN SYRINGE WITH ATTACHED NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

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	06/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 the 1 ml bd safetyglide¿ insulin syringe with attached needle experienced foreign matter in the device cannula.The following information was provided by the initial reporter: syringe - when injecting a vaccine, it is found to have a floating substance inside, which moves with the liquid.The problem product is one.
Event or Problem Description
It was reported that the 1 ml bd safetyglide¿ insulin syringe with attached needle experienced foreign matter in the device cannula.The following information was provided by the initial reporter: syringe - when injecting a vaccine, it is found to have a floating substance inside, which moves with the liquid.The problem product is one.
Additional Manufacturer Narrative
H6: investigation summary: bd vernon hills received foreign matter in empty folded blister pack.No physical syringe sample was returned.Return foreign matter sample is not in the original device , not forwarded to bd canaan for evaluation.Two photos were received.The reported device the foreign matter was reportedly found in was not returned for evaluation.Since the reported defective product was not returned, only a limited evaluation could be performed.The photos showed a piece of white round foreign matter inside a blister package not associated with this complaint.It was not possible to establish the source of foreign matter with only the foreign matter piece itself being returned.Original device with foreign matter inside as it was found is necessary to allow for a more thorough investigation.Potential root cause for the foreign matter defect could not be identified and could not be confirmed to originate at the syringe manufacturing plant.Therefore, corrective actions are not required at this time.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.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.H.6 investigation conclusion: potential root cause for the foreign matter defect could not be identified and could not be confirmed to originate at the syringe manufacturing plant.Therefore, corrective actions are not required at this time.

• Brand Name: 1 ML BD SAFETYGLIDE INSULIN SYRINGE WITH ATTACHED NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 12249931
• Report Number: 1213809-2021-00528
• Device Sequence Number: 11881518
• Product Code: FMI
• 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: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2021

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?: No
• Initial Date Received by Manufacturer: 06/30/2021
• Supplement Date Received by Manufacturer: 09/16/2021
• Initial Report FDA Received Date: 07/29/2021
• Supplement Report FDA Received Date: 10/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1