MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS NEEDLE SFTYGLD 23X1 RB MCK

Model Number	192-N231S
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of birth: only the patient's age was provided, therefore a default date of birth has been listed a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that the needle sftygld 23x1 rb mck experienced a needle that was loose/pulled out of hub.The following information was provided by the initial reporter: material no: 306610, batch no: 0141219.During a routine flu vaccination administration, a safety needle was used.Administration completed without an issue, however, once the needle was attempted to be retracted from the patients skin, the provider reported the following: "[i] was able to give the vaccine but when pulling out the needle, it remained in the patients skin sticking from the right thigh.I was able to pull the needle out with my hand with no injury or harm to the patient".We had a safety needle separate from the assembly and remain in the patient during a routine flu vaccination administration.
Additional Manufacturer Narrative
H.6.Investigation: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.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 h.10.
Event or Problem Description
It was reported that the needle sftygld 23x1 rb mck experienced a needle that was loose/pulled out of hub.The following information was provided by the initial reporter: material no: 306610, batch no: 0141219.During a routine flu vaccination administration, a safety needle was used.Administration completed without an issue, however, once the needle was attempted to be retracted from the patients skin, the provider reported the following: "[i] was able to give the vaccine but when pulling out the needle, it remained in the patients skin sticking from the right thigh.I was able to pull the needle out with my hand with no injury or harm to the patient".We had a safety needle separate from the assembly and remain in the patient during a routine flu vaccination administration.

• Brand Name: NEEDLE SFTYGLD 23X1 RB MCK
• Common Device Name: NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 11091469
• Report Number: 1213809-2020-00927
• Device Sequence Number: 17042977
• Product Code: FMI
• UDI-Device Identifier: 10612479248554
• UDI-Public: 10612479248554
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2020

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: 04/30/2025
• Device Model Number: 192-N231S
• Device Catalogue Number: 306610
• Device Lot Number: 0141219
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/01/2020
• Supplement Date Received by Manufacturer: 12/30/2020
• Initial Report FDA Received Date: 12/29/2020
• Supplement Report FDA Received Date: 12/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 2 YR