MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD SAFETYGLIDE¿ NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305905
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2021
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 when using the bd safetyglide¿ needle the stopper was defective/deformed/misaligned.This event occurred 2 times.The following information was provided by the initial reporter.The customer stated: "the needle core rubber stopper is skewed.".
Event or Problem Description
It was reported when using the bd safetyglide¿ needle the stopper was defective/deformed/misaligned.This event occurred 2 times.The following information was provided by the initial reporter.The customer stated: "the needle core rubber stopper is skewed.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 11/15/2021.H.6.Investigation: it was reported the rubber stopper is skewed.To aid in the investigation, two samples in opened packaging blisters and two photos were provided for evaluation by our quality team.A visual inspection was performed.Each of the samples has residues of a brown drug adhered to the rubber stopper.The rubber stoppers are properly assembled to the plunger rod.The customer has observed an acceptable imperfection.No other defects or imperfections were observed.In the two photos provided, one photo shows a syringe and the other photo shows two packaging blisters.A device history record review was completed for provided material number 305905, lot number 1081066.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.Monitoring of the syringe stopper will be done during inspections to verify if an unacceptable product has been assembled or packaged.To date, there have been no other similar events reported for this lot.Based on the investigation and with the returned sample analysis the symptom reported by the customer could not be confirmed.H3 other text : see h.10.

• Brand Name: BD SAFETYGLIDE¿ NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12832438
• Report Number: 1911916-2021-01167
• Device Sequence Number: 14595357
• Product Code: FMI
• UDI-Device Identifier: 30382903059059
• UDI-Public: 30382903059059
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K980987
• 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): 11/19/2021

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: 02/28/2026
• Device Model Number: 305905
• Device Catalogue Number: 305905
• Device Lot Number: 1081066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2021
• Supplement Date Received by Manufacturer: 11/19/2021
• Initial Report FDA Received Date: 11/17/2021
• Supplement Report FDA Received Date: 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2021
• 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