MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL NEEDLE INTEGRA 18X1-1/2 BLUNT FILL; PISTON SYRINGE

Model Number	305275
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: it was reported the nurses are experiencing low suction, and loss of air when plunged into the vial.Also, the needle does not seem to thread securely to the syringe and will snap off.To aid in the investigation, eight samples in sealed packaging blisters were received for evaluation by our quality team.A visual inspection was performed and no defects or imperfections were observed.Additionally, three 3ml syringes filled with saline solution came in sealed packaging blisters.Each needle assembly was tested finding no connectivity or leakage issues.A device history record review was completed for provided material number 305275, lot number 0080090.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.Based on the investigation and with the returned sample analysis the symptom reported by the customer could not be confirmed and a probable root cause could not be offered.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.Investigation conclusion: we will continue monitoring the complaint trend for this product and symptom.Probable root cause is unknown.
Event or Problem Description
It was reported that needle integra 18x1-1/2 blunt fill experienced a case of the syringe and mating component separating, and the tip/luer of syringe breaking off.The following information was provided by the initial reporter: lately, the nurses are experience low suction, and loss of air when plunged into the vial.Also it does not seem to thread securely to the syringe and will snap off.

• Brand Name: NEEDLE INTEGRA 18X1-1/2 BLUNT FILL
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 12095119
• Report Number: 1911916-2021-00617
• Device Sequence Number: 3848784
• Product Code: MEG
• UDI-Device Identifier: 30382903052753
• UDI-Public: 30382903052753
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K011103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/18/2021

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: 06/30/2022
• Device Model Number: 305275
• Device Catalogue Number: 305275
• Device Lot Number: 0080090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 06/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1