MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO BD¿NEEDLE 22GA 1-1/2IN; PISTON SYRINGE

Catalog Number 302354

Device Problems Leak/Splash (1354); Material Separation (1562)

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

Event Date 06/15/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that 2 bd¿needle 22ga 1-1/2in needles pulled out of hub and leaked.The following information was provided by the initial reporter translated from spanish to english : it was reported by the customer that the anesthesiologist puts medicine in a 10 cm syringe, removes the needle and places the needle 22 to infiltrate when injecting the medicine, it is observed that it comes out through the walls of the needle and after this the needle (metal part) detaches from the plastic part, leaving the needle into the patient's skin, the metal part can be removed without complication.Sample not sent.

Manufacturer Narrative

The following fields were updated due to additional information: d.4.Medical device lot #: 0049727.D.4.Medical device expiration date: 31-jan-2025.H.4.Device manufacture date: 06-apr-2020.

Event Description

It was reported that 2 bd¿needle 22ga 1-1/2in needles pulled out of hub and leaked.The following information was provided by the initial reporter translated from spanish to english : it was reported by the customer that the anesthesiologist puts medicine in a 10 cm syringe, removes the needle and places the needle 22 to infiltrate when injecting the medicine, it is observed that it comes out through the walls of the needle and after this the needle (metal part) detaches from the plastic part, leaving the needle into the patient's skin, the metal part can be removed without complication.Sample not sent.

Manufacturer Narrative

H6: investigation summary since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.

Event Description

It was reported that 2 bd¿needle 22ga 1-1/2in needles pulled out of hub and leaked.The following information was provided by the initial reporter translated from spanish to english : it was reported by the customer that the anesthesiologist puts medicine in a 10 cm syringe, removes the needle and places the needle 22 to infiltrate when injecting the medicine, it is observed that it comes out through the walls of the needle and after this the needle (metal part) detaches from the plastic part, leaving the needle into the patient's skin, the metal part can be removed without complication.Sample not sent.

Manufacturer Narrative

H6: investigation summary: no samples or photos received by the quality team for investigation.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Based on our investigation and given the device records did not identify any failures related to this incident, we are not able to determine a root cause related to our manufacturing process at this time.However, incident reported is confirmed.Bd has previously implemented actions to reduce this failure, including updating vision system, changing epoxy dose system, and notifying manufacturing personnel of this incident to increase awareness.

Event Description

It was reported that 2 bd¿needle 22ga 1-1/2in needles pulled out of hub and leaked.The following information was provided by the initial reporter translated from spanish to english: it was reported by the customer that the anesthesiologist puts medicine in a 10 cm syringe, removes the needle and places the needle 22 to infiltrate when injecting the medicine, it is observed that it comes out through the walls of the needle and after this the needle (metal part) detaches from the plastic part, leaving the needle into the patient's skin, the metal part can be removed without complication.Sample not sent.

• Brand Name: BD¿NEEDLE 22GA 1-1/2IN
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• Manufacturer (Section G): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15030055
• MDR Text Key: 304716531
• Report Number: 9614033-2022-00060
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: UNKNOWN
• 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,Followup,Followup
• Report Date: 10/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 302354
• Device Lot Number: 0049727
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2020
• 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