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

Model Number 409442

Device Problem Complete Blockage (1094)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/27/2020

Event Type  malfunction  

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 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.".

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 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
• Type of Device: 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
• MDR Text Key: 274008046
• Report Number: 2618282-2021-00058
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 30382904094424
• UDI-Public: 30382904094424
• Combination Product (y/n): Y
• Reporter Country Code: MX
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 09/01/2021
• Initial Date FDA Received: 09/29/2021
• Supplement Dates Manufacturer Received: 11/11/2021
• Supplement Dates FDA Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Sex: Female