MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD U-500 INSULIN SYRINGES; SYRINGE, PISTON

Device Problem Product Quality Problem (1506)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/24/2017

Event Type  malfunction  

Event Description

I am the pharmacy chief at the (b)(6).The incident i'm reporting was a 'near miss' but might be worthy of publication to prevent a similar error elsewhere.If necessary, you can contact me via email or phone at (b)(6).Here is an e-mail i sent out to all (b)(6) pharmacy chiefs regarding the incident on (b)(6) 2017: we had an incident that i am compelled to warn you about in case a similar error could be happening at your facility.As you probably know, bd u-500 insulin syringes recently came to market.We found out today that some providers have been selecting these syringes via cpoe in error for patients who are not on u-500 insulin!i strongly encourage every facility to run a search to find out which patients have been dispensed u-500 syringes, and run a search to identify your patients on u-500 insulin.Compare the two lists.Any patient who has been dispensed u-500 syringes but is not on u-500 insulin should be contacted asap.That is precisely what our facility did today.We identified 8 erroneous u-500 syringe prescriptions.Two of those never left the pharmacy.The remaining 6 patients were contacted by telephone today.No patients were harmed, all are aware of the error, and know not to use these syringes.We are expediting the correct syringes to those patients who need them now.We entered these into our local drug file on 01/03/2017.The drug file entry looks like this and can be easily overlooked by both the prescriber and finishing pharmacist: syringe insulin syringe 0.5ml 31g 6mm (u-500) xa854 100/box, for use w/insulin 500 unit/ml we have created a 'quick order' for u-500 syringes to minimize the risk of providers inadvertently selecting this item during routine order entry.I am relieved that no patients were harmed, and i wanted to get the word out to the (b)(6) pharmacy staff as quickly as possible.Hopefully, a similar error has not occurred at your facility.(b)(4).

• Brand Name: BD U-500 INSULIN SYRINGES
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; holdrege NE
• MDR Report Key: 6507682
• MDR Text Key: 73451302
• Report Number: MW5069216
• Device Sequence Number: 1
• Product Code: FMF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 02/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/18/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1