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

Catalog Number 405075

Device Problem Fracture (1260)

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

Event Date 12/19/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4): initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.

Event Description

We've received a notification for the 27g pencil point needle with introducer ref;p279g brand: bd.Lot: 2208017.Expiry date: 31/07/2027.1 unit of this product came with a defective locking needle.Additional information received 19.Dec.2023 what is the batch and catalog of the product? r- available in fup was the reported incident observed before, during or after use on the patient? a- before, when opening the product.Was there any harm to the patient/healthcare professional? (detail).A- no, when the employee opened the product, she detected a crack; was there a need for medical and/or surgical intervention due to the incident (imaging exams, surgery, medication administration, etc.)? (details).A- no, the product was replaced before starting the procedure.What medication was being administered? r- none is the incident-related sample available for analysis? if so, how many units? (we collect a maximum of 10 units for analysis purposes).A- we contacted the employee at the surgical center who made the notification, to check if there is a sample, we are awaiting a response.For product registration and replacement purposes, please inform: info available in fup/attached mail.Contact person and telephone number: (b)(6).Is the sample contaminated? if so, provide the substance.A- there is no sample.Could you send photos of the sample? a- no images were attached to the notification.Has anvisa already been notified? if so, what was the notification number? a- no.Response received on 03jan2024.What is the exact issue with the needle.? was is bent? was there a clog when attempting to use the needle? as we have already reported by email, the nurse (notifier) opened the packaging of the needle, detected a crack, opened a technical complaint and discarded the material without using it.Due to the absence of a sample and photos, we will disregard the notification.(b)(6).(b)(6) 2024.

Event Description

No additional information.

Manufacturer Narrative

Pr (b)(6)- follow up mdr #3 for correction following the submission of the initial mdr, it was noted that the incorrect manufacturing site was chosen and the site registration number was incorrect on the mdr.Mdr#: 1625685-2024-00003 will be void and a new mdr with the corrected site registration will be submitted.

Event Description

No additional information.

Manufacturer Narrative

Pr (b)(4) - follow up mdr #2 for correction.Site legal name and site registration number updated to reflect the correct manufacturing site as this was incorrectly reported in the initial mdr.

Manufacturer Narrative

(b)(4),follow up mdr for device evaluation: no photos or physical samples that display the reported condition were available for investigation.A device history review was performed for reported lot 2208017, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Three retained samples of the reported lot were used for additional evaluation.The products were visually inspected and no damage or defects on any of the needles or device components were observed.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.Based on our investigation, we are not able to identify a definitive root cause at this time.Complaints received for this device and reported issue will continue to be tracked and trended for future occurrence.H3 other text : see manufacturer narrative.

Event Description

We've received a notification for the 27g pencil point needle with introducer ref;(b)(4), brand: bd; lot: 2208017; expiry date: 31/07/2027.(b)(4) unit of this product came with a defective locking needle.Additional information received 19.Dec.2023.What is the batch and catalog of the product? r- available in fup.Was the reported incident observed before, during or after use on the patient? a- before, when opening the product.Was there any harm to the patient/healthcare professional? (detail).A- no, when the employee opened the product, she detected a crack; was there a need for medical and/or surgical intervention due to the incident (imaging exams, surgery, medication administration, etc.)? (details).A- no, the product was replaced before starting the procedure.What medication was being administered? r- none.Is the incident-related sample available for analysis? if so, how many units? (we collect a maximum of (b)(4) units for analysis purposes).A- we contacted the employee at the surgical center who made the notification, to check if there is a sample, we are awaiting a response.For product registration and replacement purposes, please inform: info available in fup/attached mail.Contact person and telephone number: r- (b)(6).Is the sample contaminated? if so, provide the substance.A- there is no sample.Could you send photos of the sample? a- no images were attached to the notification.Has anvisa already been notified? if so, what was the notification number? a- no.Response received on 03jan2024.What is the exact issue with the needle.? was is bent? was there a clog when attempting to use the needle? as we have already reported by email, the nurse (notifier) opened the packaging of the needle, detected a crack, opened a technical complaint and discarded the material without using it.Due to the absence of a sample and photos, we will disregard the notification.- (b)(6),(b)(6) 2024.

• 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
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18516913
• MDR Text Key: 333545421
• Report Number: 1625685-2024-00003
• Device Sequence Number: 1
• Product Code: MIA
• UDI-Device Identifier: 00382904050757
• UDI-Public: (01)00382904050757
• 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,Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/16/2024

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: Health Professional
• Device Catalogue Number: 405075
• Device Lot Number: 2208017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/19/2023
• Initial Date FDA Received: 01/16/2024
• Supplement Dates Manufacturer Received: 01/25/2024; 01/25/2024; 01/25/2024
• Supplement Dates FDA Received: 01/26/2024; 04/16/2024; 04/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1