MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD¿ QUINCKE SPINAL NEEDLES; NEEDLE, CONDUCTION, ANESTHETIC

Catalog Number 405259

Device Problem Leak/Splash (1354)

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

Event Date 02/10/2023

Event Type  malfunction  

Event Description

It was reported that the bd¿ quincke spinal needles experienced leakage at connection site.This is 3 of 3 related events.The following information was provided by the initial reporter: during the administration of anesthesia with 3 different needles despite an adequate syringe containing the local anesthetic, the medication leaks through the needle tie, losing the medication; on one occasion with a patient it led to failure of the spinal block.Additional information received on 09.Mar.2023: did the drug leak occur in 3 different patients?: it happened in all 3 patients.Did the 3 patients have to be given the drug again with another needle?: yes, to the 3 patients.It is mentioned that one of the patients did not have a spinal block due to the loss of medication, what happened?: he was given general anesthesia.Are the products involved available for analysis?: the needles are thrown away.Were the 3 needles from the same batch? if not, could you please advise the lot numbers of c/needle?: it is unknown (the packaging of one of the needles was provided with the report).

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device expiration date: unknown.Device manufacture date: unknown.

Event Description

It was reported that the bd¿ quincke spinal needles experienced leakage at connection site.This is 3 of 3 related events.The following information was provided by the initial reporter: during the administration of anesthesia with 3 different needles despite an adequate syringe containing the local anesthetic, the medication leaks through the needle tie, losing the medication; on one occasion with a patient it led to failure of the spinal block.__ additional information received on 09.Mar.2023: 1.Did the drug leak occur in 3 different patients? a: it happened in all 3 patients.Did the 3 patients have to be given the drug again with another needle? a: yes, to the 3 patients.2.It is mentioned that one of the patients did not have a spinal block due to the loss of medication, what happened? a: he was given general anesthesia.3.Are the products involved available for analysis? a: the needles are thrown away.4.Were the 3 needles from the same batch? if not, could you please advise the lot numbers of c/needle? a: it is unknown (the packaging of one of the needles was provided with the report).

Manufacturer Narrative

H6: investigation summary: no physical samples that display the reported condition were provided to our quality team for investigation.A device history review could not be performed.Based on the available information we are not able to identify a root cause at this time.

• Brand Name: BD¿ QUINCKE SPINAL NEEDLES
• Type of Device: NEEDLE, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16547665
• MDR Text Key: 311672736
• Report Number: 3003152976-2023-00070
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K210978
• 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: 03/17/2023

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 Catalogue Number: 405259
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/17/2023
• Initial Date FDA Received: 03/15/2023
• Supplement Dates Manufacturer Received: 03/17/2023
• Supplement Dates FDA Received: 03/28/2023
• 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