MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD SYRINGE

Catalog Number UNKNOWN

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 06/14/2019

Event Type  malfunction  

Manufacturer Narrative

There are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.(b)(4).Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: two (2) photos were provided by the customer for investigation.One (1) photo shows a plunger stopper in a 20ml barrel.There is a yellow rectangle highlighting what appears to be 3 or 4 drops of liquid between the plunger stopper ribs.The second (2nd) photo also shows a plunger stopper in a syringe barrel.There are two (2) red rectangles highlighting two (2) areas of the plunger in the barrel.One (1) rectangle highlights what appears to be 4 drops of liquid between the plunger stopper ribs.The second (2nd) rectangle highlights what appears to be a dark area between the plunger stopper ribs.Leakage can be caused by the interaction between the barrel inside diameter, the stopper outside diameter, and plunger rod bayonet outside diameter and forces applied during use.The syringe is more likely to leak when forces are applied to the plunger rod when fully extended.Bd defines leakage as liquid which escapes past the stopper ribs into the barrel.A device history record review could not be completed as no batch number was provided.Investigation conclusion: based on the photo provided it cannot be determined if the liquid in the syringe has escaped past the stopper ribs into the barrel.Therefore, based on the photo provided the condition reported by the customer cannot be confirmed.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.Root cause description: bd defines leakage as liquid which escapes past the stopper ribs into the barrel.Based on the photo provided it cannot be determined if the liquid in the syringe has escaped past the stopper ribs into the barrel.Therefore, based on the photo provided the condition reported by the customer cannot be confirmed.Rationale: based on the investigation conclusion, the condition reported by the customer could not be confirmed nor could this symptom be correlated with a potential cause linked to the bd process.Therefore, no corrective or preventative actions are proposed in the scope of this complaint.

Event Description

It was reported that before use of the unspecified bd¿ syringe there was leakage or "bleeding" behind the barrel of the syringe.The following information was provided by the initial reporter: "we have a fluorouracil syringe we received this morning with bleeding into the barrel bung.".

• Brand Name: UNSPECIFIED BD SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 8765405
• MDR Text Key: 150704054
• Report Number: 2243072-2019-01337
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/25/2019

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: UNKNOWN
• Device Lot Number: 111101708
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/14/2019
• Initial Date FDA Received: 07/05/2019
• 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): Other