MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL INJECTOR LUER LOCK N35C; INTRAVASCULAR ADMINISTRATION SET

Model Number	515004
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
Event or Problem Description
It was reported that an unspecified number of bd phaseal¿ injector luer lock n35c experienced needle exposure -defective injector during use.The following information was provided by the initial reporter: after preparation when the nurse removed the injector from the protector, the needle was still out and the nurse stuck herself on the needle.The injector had not been in contact with any patient but only with medication.Additional information: today i received response from the sales representative, it is not possible to obtain the lot number for this complaint.
Additional Manufacturer Narrative
H.6.Investigation: one photo was provided to our quality team for investigation.Upon visual inspection of the product, the needle was observed to be exposed.It was also identified that the grips on the safety sleeve were dislocated from the intended place.As the lot involved in this incident was unknown, a device history review could not be performed.It seems that a misuse of the device by the user during the disconnection of the injector can be established as the root cause of the incidence reported causing the damage of the grips being removed from their place and leading to the needle exposure.It may be considered that: if grips of the safety sleeve are removed from their place, the injector is activated causing needle exposure.The injector must be removed pulling it back: if it is removed without doing this the grips are removed from their place and needle exposure happens.If the injector has been forced while engaging, the grips can also get damaged.
Event or Problem Description
It was reported that an unspecified number of bd phaseal¿ injector luer lock n35c experienced needle exposure -defective injector during use.The following information was provided by the initial reporter: after preparation when the nurse removed the injector from the protector, the needle was still out and the nurse stuck herself on the needle.The injector had not been in contact with any patient but only with medication.Additional information: today i received response from the sales representative ¿ it is not possible to obtain the lot number for this complaint.

• Brand Name: BD PHASEAL INJECTOR LUER LOCK N35C
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 10655612
• Report Number: 3003152976-2020-00437
• Device Sequence Number: 3777695
• Product Code: ONB
• UDI-Device Identifier: 30382905150044
• UDI-Public: 30382905150044
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K140591
• Number of Events Summarized: 1
• Summary Report (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): 10/23/2020

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 Model Number: 515004
• Device Catalogue Number: 515004
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/16/2020
• Supplement Date Received by Manufacturer: 09/16/2020
• Initial Report FDA Received Date: 10/09/2020
• Supplement Report FDA Received Date: 10/23/2020
• 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