MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD ANESTHESIA SYRINGE

Catalog Number UNKNOWN

Device Problem Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/23/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.The customer's address is unknown.(b)(6), usa was determined by the provided phone number.Device manufacture date: unknown.(b)(4).Unknown manufacturer: (b)(4).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.We would be very interested in examining product that does not meet your expectations and our quality standards.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.Examination of the product involved may provide clarification as to the cause for the reported failure.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.  our business team regularly reviews the collected data for identification of emerging trends.Investigation conclusion: part number and lot number is unknown; a lot history review could not be performed.Root cause description: no root cause can be determined as no samples were received.Rationale: capa is not required at this time.

Event Description

It was reported that an unspecified anesthesia syringe had poor package perforation.The following information was provided by the initial reporter: "it was reported that the saline flushes are not perforated.Event description per attached email states: i got a call from our recovery room that our sterile saline flushes are not perforated so they are ripping through as they rip off another one.Have you heard anything about these? we don't know how many boxes since they have to be taken out of the box when we bring them in.".

• Brand Name: UNSPECIFIED BD ANESTHESIA SYRINGE
• Type of Device: ANESTHESIA SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 10413001
• MDR Text Key: 206109381
• Report Number: 2243072-2020-01257
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial
• Report Date: 07/30/2020

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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/23/2020
• Initial Date FDA Received: 08/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other