MAUDE Adverse Event Report: BECTON DICKINSON WHITACRE SET 27GA 3-1/2IN; NEEDLE, SPINAL, SHORT TERM

Catalog Number 405075

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/13/2023

Event Type  Injury  

Event Description

Patient underwent caesarean section on (b)(6) 2023.During a puncture for spinal anesthesia, the 27g whitacre needle was traumatized, and a fragment of the object remained lodged in the patient's spine.This happened on my shift, but i didn't open complaint, because the anesthesiologist himself told the patient and the team that this case could occur because the needle had "hit" the bone and broke during handling.So i understood that it wouldn't be a problem with the material, since the same type of needle was requested to continue the procedure and other procedures took place on the same day, using the same one.I contacted the pharmacy and shared the case with the pharmacist, who also felt that it wasn't a case of opening technovigilance, since the material hadn't been damaged before use.All the material was discarded.Impact on the patient: ".Fragment of the object remains lodged in the patient's spine.Additional information available in the email chain: patient underwent cesarean section on (b)(6) 2023.During puncture for spinal anesthesia, trauma occurs from the 27g withacre needle and a fragment of the object remains lodged in the patient's spine.The suspicion was confirmed through radioscopy and at the same time an evaluation was requested from the back-up neurosurgery team.Doctor attends, evaluates case and recommends removal of foreign body for (b)(6) 2023 at 3:00 pm.On 11/14, after a morning visit by her attending physician, the patient expressed her refusal to undergo a needle fragment removal procedure.Procedure suspended.Later at 9:00 pm on the same day, the doctor proceeds to remove a needle fragment under local anesthesia.I can't find any record of antibiotic prophylaxis before the procedure.____ additional information received on 26.Nov.2023: ¿ could you share the patient's status? a: patient discharged from hospital.¿ what specific information did the anesthesiologist provide about the incident and how it occurred? a: at the time of the incident, the anesthetist informs that problems like this can happen, that the needle could have "hit" the muscle or bone, and even though this event is rare.¿ can you tell us what safety measures were taken after the incident and after surgery? a: scope was performed and a neurosurgeon was called on duty.¿ can you explain why the patient refuses to remove the needle fragment? any specific medical conditions? a: the fragment was removed on 11/14 at 9:30 pm, without any complications.¿ was anvisa notified? if so, what was the notification number? (no response from customer) __ additional information received on 27.Nov.2023: batch number is 2306011.

Manufacturer Narrative

(b)(4): initial mdr submission.A follow up mdr will be submitted if a device evaluation and/or device history review is completed.Patient problem code: e2008 - foreign body in patient f1903 - device explantation device problem code: a0401 ¿ break.

Event Description

Patient underwent caesarean section on (b)(6) 2023.During a puncture for spinal anesthesia, the 27g whitacre needle was traumatized, and a fragment of the object remained lodged in the patient's spine.This happened on my shift, but i didn't open complaint, because the anesthesiologist himself told the patient and the team that this case could occur because the needle had "hit" the bone and broke during handling.So i understood that it wouldn't be a problem with the material, since the same type of needle was requested to continue the procedure and other procedures took place on the same day, using the same one.I contacted the pharmacy and shared the case with the pharmacist, who also felt that it wasn't a case of opening technovigilance, since the material hadn't been damaged before use.All the material was discarded.Impact on the patient: ".Fragment of the object remains lodged in the patient's spine.Additional information available in the email chain: patient underwent cesarean section on (b)(6) 2023.During puncture for spinal anesthesia, trauma occurs from the 27g withacre needle and a fragment of the object remains lodged in the patient's spine.The suspicion was confirmed through radioscopy and at the same time an evaluation was requested from the back-up neurosurgery team.Doctor attends, evaluates case and recommends removal of foreign body for (b)(6) 2023 at 3:00 pm.On (b)(6), after a morning visit by her attending physician, the patient expressed her refusal to undergo a needle fragment removal procedure.Procedure suspended.Later at 9:00 pm on the same day, the doctor proceeds to remove a needle fragment under local anesthesia.I can't find any record of antibiotic prophylaxis before the procedure.Additional information received on 26.Nov.2023: could you share the patient's status? a: patient discharged from hospital.What specific information did the anesthesiologist provide about the incident and how it occurred? a: at the time of the incident, the anesthetist informs that problems like this can happen, that the needle could have "hit" the muscle or bone, and even though this event is rare.Can you tell us what safety measures were taken after the incident and after surgery? a: scope was performed and a neurosurgeon was called on duty.Can you explain why the patient refuses to remove the needle fragment? any specific medical conditions? a: the fragment was removed on (b)(6) at 9:30 pm, without any complications.Was anvisa notified? if so, what was the notification number? (no response from customer).Additional information received on 27.Nov.2023: batch number is 2306011.

Manufacturer Narrative

Pr (b)(4) follow up mdr for device evaluation: one photo which displays the product information was provided, however, no photo or physical sample that display the reported condition were available for investigation.A device history review was performed for reported lot 2306011, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Three retained samples of the same lot were used for additional evaluation.The product was visually inspected, no damage or defects were observed on any of the needles.Product undergoes visual inspections throughout the manufacturing process according to procedure, verifying there are no defects or damage on the product.Lot release testing results were reviewed for the reported lot and no issues were identified.The details initially provided when reporting this incident indicate the needle broke during procedure due to hitting the bone.Based on the available information, we are not able to identify a root cause related to our manufacturing process at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.

• Brand Name: WHITACRE SET 27GA 3-1/2IN
• Type of Device: NEEDLE, SPINAL, SHORT TERM
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix IL 60061
• Manufacturer Contact: helen cox ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18282906
• MDR Text Key: 329943427
• Report Number: 3003152976-2023-00525
• Device Sequence Number: 1
• Product Code: MIA
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K210978
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 405075
• Device Lot Number: 2306011
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR
• Patient Sex: Female