MAUDE Adverse Event Report: BECTON DICKINSON HEPARIN 100UL 5ML FILL IN 10ML SYRINGE

Model Number	306513
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Oem manufacture: the manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Therefore, (b)(4) corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.
Event or Problem Description
It was reported that the heparin 100ul 5ml fill in 10ml syringe was involved with the receipt of an expired product.Product defect was noted during use.The following information was provided by the initial reporter: material # 306513 lot# 806871.The product was sent with an expiration date on the box and all of the syringes.The product was in date when received.We use minimal of the product and when the rn used the product to flush the port the product was expired.On the 19th of march i used 10cc one syringe of heparin solution to flush a port.The heparin had expired on the 8th march.
Additional Manufacturer Narrative
H.6.Investigation: a device history record review was performed for provided lot number 806871n and the review revealed that all in-process and final release inspections met specification during the production process.As stated in the provided customer feedback, the product was received at the facility within its shelf-life; however, the product was not used prior to its expiration.As documented within the instructions for use, it is important that the expiration date is confirmed prior to use.There is no current complaint trend for aseptic prefilled syringes in the last 12 months.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of expired product for aseptic prefilled syringes in the last 24 months.No trend of expired product has been identified.
Event or Problem Description
It was reported that the heparin 100ul 5ml fill in 10ml syringe was involved with the receipt of an expired product.Product defect was noted during use.The following information was provided by the initial reporter: material # 306513 lot# 806871 the product was sent with an expiration date on the box and all of the syringes.The product was in date when received.We use minimal of the product and when the rn used the product to flush the port the product was expired.On the (b)(6) march i used 10cc one syringe of heparin solution to flush a port.The heparin had expired on the (b)(6) march.

• Brand Name: HEPARIN 100UL 5ML FILL IN 10ML SYRINGE
• Common Device Name: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 10035305
• Report Number: 2243072-2020-00734
• Device Sequence Number: 16782512
• Product Code: FMF
• UDI-Device Identifier: 30382903065135
• UDI-Public: 30382903065135
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K163591
• 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,Followup
• Report Date (Section B): 05/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 03/08/2020
• Device Model Number: 306513
• Device Catalogue Number: 306513
• Device Lot Number: 806871N
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/15/2020
• Supplement Date Received by Manufacturer: 04/15/2020
• Initial Report FDA Received Date: 05/07/2020
• Supplement Report FDA Received Date: 05/08/2020
• 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