MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY SYRINGE 5ML HEPARIN 100 UNIT; HEPARIN, VASCULAR ACCESS FLUSH

Catalog Number	306424
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device expiration date: unknown.Device manufacture date: unknown.(b)(6).Investigation summary: resolution plan outline prepared for (b)(6) short-term (within 30 days): identify a list of products that could potentially cause patient harm if substituted incorrectly and provide a relevant, accurate cross-reference product for each part number.Upload information into the existing e-catalog on bd.Com.Notify bd associates on how to access the cross-reference information.Mid-term (est.Q1 fy20): update the new catalog platform with the cross-reference information list.Notify bd associates on how to access the cross-reference information.Long-term (est.Beginning q2 fy20): transition to hosted version of e-catalog that includes specific fields for product substitutes.Update designated fields with the cross-reference information.Notify bd associates how to access the cross-reference information.No dhr could be conducted as no lot# was given.
Event or Problem Description
It was reported that label error was found before use with a syringe 5ml heparin 100 unit.The following information was provided by the initial reporter, "customer converted from standard flush to bd posiflush syringes and heparin - an error in the cross reference caused the customer to order 100ups units/ml instead of 10ups units/ml.Product made it all the way to the end used fortunately, the nurse recognized the color coding and questioned this syringe to avoid adverse patient outcome.".

• Brand Name: SYRINGE 5ML HEPARIN 100 UNIT
• Common Device Name: HEPARIN, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY; 2153 12th avenue; columbus NE 68601
• MDR Report Key: 8903219
• Report Number: 1911916-2019-00828
• Device Sequence Number: 1504558
• Product Code: NZW
• UDI-Device Identifier: 30382903064244
• UDI-Public: 30382903064244
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K090680
• 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): 08/06/2019

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: Other
• Device Catalogue Number: 306424
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2019
• Initial Report FDA Received Date: 08/16/2019
• 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