MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD SYRINGE 5ML HEPARIN; 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	08/06/2019
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.
Event or Problem Description
Material no.306424, batch no.827575n.It was reported that before use of the bd syringe 5ml heparin the heparin flush syringe was missing the labeling.The following information was provided by the initial reporter: a unit rn brought to the pharmacy¿s attention a heparin flush without any identification.Since they are loaded by box, its sister syringes belong to lot: 827575n, exp: 9/30/2020.The nurses also commented that this is not the first one they have found without a label, only the first brought to pharmacy¿s attention.
Additional Manufacturer Narrative
H.6.Investigation: two samples were received for investigation.Both have the plunger rod-rubber stopper, the tip cap and solution, one has the barrel label missing.The one with barrel label came in the sealed packaging flow wrap, the other syringe doesn¿t have it.Additionlly, one photo was provided.Two syringes are shown in the photo, one has barrel label and the other one has no barrel label.Both have the plunger rod-rubber stopper, tip cap, and solution.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Possible root cause is the plunger rod labeler machine.No corrective action at this time.
Event or Problem Description
Material no.306424, batch no.827575n.It was reported that before use of the bd syringe 5ml heparin the heparin flush syringe was missing the labeling.The following information was provided by the initial reporter: a unit rn brought to the pharmacy¿s attention a heparin flush without any identification.Since they are loaded by box, its sister syringes belong to lot: 827575n, exp: 9/30/2020.The nurses also commented that this is not the first one they have found without a label, only the first brought to pharmacy¿s attention.

• Brand Name: BD SYRINGE 5ML HEPARIN
• Common Device Name: HEPARIN, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 8931027
• Report Number: 1911916-2019-00856
• Device Sequence Number: 16200012
• Product Code: NZW
• UDI-Device Identifier: 30382903064244
• UDI-Public: 30382903064244
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K090680
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2019

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 Expiration Date: 09/30/2020
• Device Catalogue Number: 306424
• Device Lot Number: 827575N
• Initial Date Received by Manufacturer: 08/08/2019
• Supplement Date Received by Manufacturer: 08/08/2019
• Initial Report FDA Received Date: 08/26/2019
• Supplement Report FDA Received Date: 09/04/2019
• 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