MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD TUBERCULIN SYRINGE WITH BD PRECISIONGLIDE DETACHABLE NEEDLE; PISTON SYRINGE

Catalog Number	309623
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 bd precisionglide¿ detachable needle had separated from the bd¿ tuberculin syringe and remained inside the cap when removing it during use.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "consumer reported when she removes the cap from the needle, the needle and hub remains inside the cap.She uses the plyer to remove the needle.She uses twice a day, she has about 14 needle detached from the hub remained in the needle shield.".
Additional Manufacturer Narrative
Investigation summary: no samples displaying the condition reported are available for examination, so 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 the bd precisionglide¿ detachable needle had separated from the bd¿ tuberculin syringe and remained inside the cap when removing it during use.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "consumer reported when she removes the cap from the needle, the needle and hub remains inside the cap.She uses the plyer to remove the needle.She uses twice a day, she has about 14 needle detached from the hub remained in the needle shield.".

• Brand Name: BD TUBERCULIN SYRINGE WITH BD PRECISIONGLIDE DETACHABLE NEEDLE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 9315376
• Report Number: 1213809-2019-01133
• Device Sequence Number: 2407966
• Product Code: FMF
• UDI-Device Identifier: 30382903096320
• UDI-Public: 30382903096320
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2019

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: Lay User/Patient
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: 309623
• Device Lot Number: 8285569
• Initial Date Received by Manufacturer: 10/29/2019
• Supplement Date Received by Manufacturer: 10/29/2019
• Initial Report FDA Received Date: 11/13/2019
• Supplement Report FDA Received Date: 12/05/2019
• 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