MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE INSULIN 1ML LL; PISTON SYRINGE

Catalog Number	309629
Medical Device Problem Codes	Leak/Splash (1354); Failure to Deliver (2338)
Health Effect - Clinical Code	Bruise/Contusion (1754)
Date of Event	09/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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.Device manufacture date: unknown.
Event or Problem Description
It was reported that the syringe insulin 1ml ll "locked up" during use with the flu vaccine, as the plunger rod required a lot of force.This complaint was created to capture the first of two related incidents.The following information was provided by the initial reporter: one of their charge nurses said that when they use the flu vaccine with the bd 1ml syringe 309629, the syringe ¿locks up¿ when they try to inject the vaccine.I personally watched a flu vaccine administration and the plunger rod could not be pressed when the flu vaccine was in the syringe unless there was a lot of force.She said they have been noticing this for approximately the last two weeks.They said they have noticed some bruising to the patient as a result.When they use a 3ml they do not experience the ¿locking¿.They don¿t think its an issue with the 1 ml but somehow perhaps the combination of the flu vaccine and the 1ml.
Event or Problem Description
It was reported that the syringe insulin 1ml ll "locked up" during use with the flu vaccine, as the plunger rod required a lot of force.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: one of their charge nurses said that when they use the flu vaccine (picture attached) with the bd 1ml syringe 309629, the syringe ¿locks up¿ when they try to inject the vaccine.I personally watched a flu vaccine administration and the plunger rod could not be pressed when the flu vaccine was in the syringe unless there was a lot of force.She said they have been noticing this for approximately the last two weeks.They said they have noticed some bruising to the patient as a result.When they use a 3ml they do not experience the ¿locking¿.They don¿t think its an issue with the 1 ml but somehow perhaps the combination of the flu vaccine and the 1ml.
Additional Manufacturer Narrative
H.6.Investigation summary: two photos were received for vaccine vial and packaging box which are not bd product.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.A device history record review could not be performed as lot number was unknown.

• Brand Name: SYRINGE INSULIN 1ML LL
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 9134587
• Report Number: 1213809-2019-00982
• Device Sequence Number: 398359
• Product Code: FMF
• UDI-Device Identifier: 30382903096290
• UDI-Public: 30382903096290
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K024112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 309629
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/12/2019
• Supplement Date Received by Manufacturer: 09/12/2019
• Initial Report FDA Received Date: 09/30/2019
• Supplement Report FDA Received Date: 10/25/2019
• 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