MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) SYRINGE 10ML LS 22GA 1-1/4IN TW; ARTERIAL CANNULA

Catalog Number 301304

Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/05/2020

Event Type  Injury  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.(b)(4).Investigation summary: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified and the root cause could not be determined.A device history record could not be evaluated as the lot number is unknown.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.Investigation conclusion: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Root cause description: root cause could not be determined as no photos and samples returned for investigation.If the sample are received in the future, the complaint will be re-opened and re-investigated.Rationale: the complaint will continue to be tracked and monitored.

Event Description

It was reported that the syringe 10ml ls 22ga 1-1/4in tw cannula separated from the hub and remained in the patient's vessel.An operation was performed to remove the pieces from the patient's body.The following information was provided by the initial reporter: "during arterial blood collection, the cannula disconnected with the adapter(hub), then the cannula left in the vessel.The personnel made an operation for the patient, then pick the cannula out of the body.".

• Brand Name: SYRINGE 10ML LS 22GA 1-1/4IN TW
• Type of Device: ARTERIAL CANNULA
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11159233
• MDR Text Key: 226831438
• Report Number: 8041187-2021-00016
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 301304
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2020
• Initial Date FDA Received: 01/13/2021
• 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
• Patient Outcome(s): Required Intervention