MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD SYRINGE

Model Number	306544
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Unknown manufacturer: 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.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.A device history review could not be completed as no batch number was provided.Investigation conclusion: 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.Based on no sample, the investigation concluded, bd was not able to verify the indicated failure.Root cause description: no root cause can be determined as no samples were received.Rationale: no batch#/sample available no further investigation required.
Event or Problem Description
It was reported that unspecified bd¿ syringe plunger movement was difficult.This was discovered during use.The following information was provided by the initial reporter: material no.Unknown batch no.Unknown.It was reported that the syringe will not allow you to infuse more than 3mls.3 of 3: direct email from customer: we have been alerted by 3 hospitals' nicus that there is issue w/the bd pre-fill 3ml ns flush syringes.Nicus utilize the alaris syringe module to flush, which does read it as a 10ml barrel but won't let you infuse more than 3mls.It does read a 10 ml barrel but it will not let you infuse more than the 3 mls.It won't even let you put in anything more than 3.Ml.I have another concern that my staff thinks these are blowing the iv's that they start.They think the pressure is different.We deal with very small patients like under 1 pound and they claim these flushes blow the iv's they are starting.Can you find out if the pressure is greater.It also feels like the barrel is harder to push.However, the major concern is that these 3ml syringes seem to be infusing w/more pressure so that it blows these nicu babies ivs.We need this investigated asap.If these do infuse w/more pressure, we may need to return to the medline 3ml syringe.We cannot have these critical patients not having access & having multiple iv restarts.

• Brand Name: UNSPECIFIED BD SYRINGE
• Common Device Name: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 9635856
• Report Number: 2243072-2020-00088
• Device Sequence Number: 18984982
• Product Code: FMF
• UDI-Device Identifier: 30382903065449
• UDI-Public: 30382903065449
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/22/2020

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
• Operator of Device: Other
• Device Model Number: 306544
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2020
• Initial Report FDA Received Date: 01/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other