MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD¿ BLUNT FILL NEEDLE; NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Catalog Number 303129

Device Problem Contamination (1120)

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

Event Date 04/24/2023

Event Type  malfunction  

Event Description

It was reported that a fragment of the rubber stopper from the medication vial had been cored by the bd¿ blunt fill needle into the syringe during use.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter, translated from spanish: "incident description: "the incident is reported to sinea (adverse event reporting system), by an anesthesiologist in the operating room: "when loading the remifentanil i noticed a fragment of rubber that had passed into the syringe from the puncture of the vial with the thick loading needle.It is a fragment that is difficult to see and is very likely to go unnoticed when loading many types of medication.We also detected the problem with propofol loading more than a month ago (04/24/2023).It is a problem that can affect the entire hospital and is going undetected, posing a risk of these rubber fragments passing into the patient's circulatory system." consequences for the patient: none other measures: "it has been assessed by the patient safety committee, and with the response of the preliminary investigation conducted by bd which concludes that the root cause of the failure could not be attributed to the bd needle, it has been agreed to continue with the use of the needle throughout the hospital except in the operating room and pharmacy clean room, with extreme vigilance for possible incidents that will be notified if they are detected.And as a precautionary measure in the operating room and pharmacy clean room, where more cases have been reported, this needle has been replaced by another needle with a filter recommended by the same manufacturer.This needle will be used in those cases in which medication is used with systems that do not have an integrated filter".".

Manufacturer Narrative

H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that a fragment of the rubber stopper from the medication vial had been cored by the bd¿ blunt fill needle into the syringe during use.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter, translated from spanish: "incident description: "the incident is reported to sinea (adverse event reporting system), by an anesthesiologist in the operating room: "when loading the remifentanil i noticed a fragment of rubber that had passed into the syringe from the puncture of the vial with the thick loading needle.It is a fragment that is difficult to see and is very likely to go unnoticed when loading many types of medication.We also detected the problem with propofol loading more than a month ago ((b)(6) 2023).It is a problem that can affect the entire hospital and is going undetected, posing a risk of these rubber fragments passing into the patient's circulatory system." consequences for the patient: none other measures: "it has been assessed by the patient safety committee, and with the response of the preliminary investigation conducted by bd which concludes that the root cause of the failure could not be attributed to the bd needle, it has been agreed to continue with the use of the needle throughout the hospital except in the operating room and pharmacy clean room, with extreme vigilance for possible incidents that will be notified if they are detected.And as a precautionary measure in the operating room and pharmacy clean room, where more cases have been reported, this needle has been replaced by another needle with a filter recommended by the same manufacturer.This needle will be used in those cases in which medication is used with systems that do not have an integrated filter".

Manufacturer Narrative

The following fields have been updated due to additional information: d.9.Device available for eval?: yes d.9.Returned to manufacturer on: 10-aug-2023 h.6.Investigation summary: a device history record review was completed for provided material number (b)(4) and lot number (b)(4).The review did not reveal any detected abnormalities during the production process that could have contributed to the reported defect and all quality tests were found to be within specification.To aid in the investigation of this issue, forty (40) unused needles were provided for evaluation by our quality team.The needles were used to puncture a laboratory vial (plastic stopper) and no difficulties were identified.After puncturing the vial, the needles were microscopically examined.No particles were observed to indicate vial stopper fragmentation and the bevels maintained proper form.Based on the preventive measures in place, it is unlikely that coring resulted from poor or insufficient de-burring of the cannula.It is possible that the stopper conditions and the handling of the product had a role in the reported incident.The needle should penetrate the vial stopper at a ninety-degree angle to minimize the risk of catching the internal wall of the vial stopper.At this time, further action has not been determined necessary.Our quality team will continue to closely monitor the manufacturing process for signs of this potential defect and any emerging trends.

• Brand Name: BD¿ BLUNT FILL NEEDLE
• Type of Device: NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer (Section G): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17480904
• MDR Text Key: 320864473
• Report Number: 3002682307-2023-00229
• Device Sequence Number: 1
• Product Code: GAA
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 303129
• Device Lot Number: 221206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2022
• 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