MAUDE Adverse Event Report: BD CARIBE LTD. NEEDLE SP S/SU 25GA 4-11/16IN WHITACRE; ANESTHESIA CONDUCTION NEEDLE

Model Number	409442
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of birth: unknown.The patient¿s age was used to determine a placeholder date for this field.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: bd was unable to perform a thorough investigation as no sample, or lot number were provided.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported needle sp s/su 25ga 4-11/16in whitacre had a blocked needle.The following information was provided by the initial reporter, translated from (b)(6): "at the time of starting the blockage, the medical and nursing staff noticed the bad state of the needle, so they proceeded to make the change.".
Additional Manufacturer Narrative
The following field was updated due to corrected information: g.5.Is combination product?: no.H.6.Investigation: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.The complaint could not be confirmed and the root cause is undetermined.
Event or Problem Description
It was reported needle sp s/su 25ga 4-11/16in whitacre had a blocked needle.The following information was provided by the initial reporter, translated from spanish: "at the time of starting the blockage, the medical and nursing staff noticed the bad state of the needle, so they proceeded to make the change.".

• Brand Name: NEEDLE SP S/SU 25GA 4-11/16IN WHITACRE
• Common Device Name: ANESTHESIA CONDUCTION NEEDLE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• Manufacturer (Section G): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12550205
• Report Number: 2618282-2021-00058
• Device Sequence Number: 5173612
• Product Code: BSP
• UDI-Device Identifier: 30382904094424
• UDI-Public: 30382904094424
• Combination Product (Y/N): Y
• Initial Reporter Country: MX
• PMA/510(K) Number: NA
• 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): 11/11/2021

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 Model Number: 409442
• Device Catalogue Number: 409442
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2021
• Supplement Date Received by Manufacturer: 11/11/2021
• Initial Report FDA Received Date: 09/29/2021
• Supplement Report FDA Received Date: 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 48 YR
• Patient Sex: Female