MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 1/2ML W/NDL 27X1/2 RB; PISTON SYRINGE

Model Number	305620
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)
Date of Event	02/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 an unspecified number of syringe 1/2ml w/ndl 27x1/2 rb were involved with dirty needle stick injuries after use.It has not been specified what, if any, medical intervention was administered or received as a result of the dirty needle stick injury.The following information was provided by the initial reporter: material no.: 305620, batch no.: unknown.Verbatim: our customer is having a large uptick in needle stick occurrences due to a safety needle not being available on our.5ml.Most have occurred after injection.The most recent was before.The nurse had a difficult time removing the cap and stuck herself.From what i can tell the needle sticks have been to nurses.Below is the information from pharmacy.These syringes are used for very small doses of lovenox.Maximum 0.5ml size (larger syringes have greater potential for overdose and cannot draw up to the 0.01ml graduations as accurately.Can visualize the smaller amounts without uncapping.The syringes have a large cap that covers the first 0.1ml graduations.The pharmacists would be unable to check the smaller doses we typically see with these patients.
Additional Manufacturer Narrative
H.6.Investigation: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A dhr check was not performed as the lot number is "unknown" for this complaint.H3 other text : see h.10.
Event or Problem Description
It was reported that an unspecified number of syringe 1/2ml w/ndl 27x1/2 rb were involved with dirty needle stick injuries after use.It has not been specified what, if any, medical intervention was administered or received as a result of the dirty needle stick injury.The following information was provided by the initial reporter: material no.: 305620 batch no.: unknown verbatim: our customer is having a large uptick in needle stick occurrences due to a safety needle not being available on our.5ml.Most have occurred after injection.The most recent was before.The nurse had a difficult time removing the cap and stuck herself.From what i can tell the needle sticks have been to nurses.Below is the information from pharmacy.These syringes are used for very small doses of lovenox.-maximum 0.5ml size (larger syringes have greater potential for overdose and cannot draw up to the 0.01ml graduations as accurately.-can visualize the smaller amounts without uncapping.The syringes have a large cap that covers the first 0.1ml graduations.The pharmacists would be unable to check the smaller doses we typically see with these patients.

• Brand Name: SYRINGE 1/2ML W/NDL 27X1/2 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 9786909
• Report Number: 1920898-2020-00203
• Device Sequence Number: 679032
• Product Code: FMF
• UDI-Device Identifier: 30382903056201
• UDI-Public: 30382903056201
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2020

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: 305620
• Device Catalogue Number: 305620
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/13/2020
• Supplement Date Received by Manufacturer: 02/13/2020
• Initial Report FDA Received Date: 03/04/2020
• Supplement Report FDA Received Date: 03/13/2020
• 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