MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY SYRINGE 5ML HEPARIN 100 UNIT

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	08/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple medical device types reported to be involved.The information for the additional device type is as follows: common device name: vascular access flush.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It has been reported that the syringe 5ml heparin 100 unit has been found missing labels before use.The following has been provided by the initial reporter: material no.306424, batch no.Unknown.It was reported that heparin flush syringe was found without labeling.Per email: a unit rn brought to 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.
Event or Problem Description
It has been reported that the syringe 5ml heparin 100 unit has been found missing labels before use.The following has been provided by the initial reporter: material no.306424, batch no.Unknown.It was reported that heparin flush syringe was found without labeling.Per email: a unit rn brought to 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: one photo was provided.It shows two syringes; one is in the sealed packaging flow wrap and has barrel label, the other syringe has no packaging flow rap and has missing the barrel label.Both have the plunger rod-rubber stopper, the tip cap, and solution.The missing barrel label comes from the plunger rod labeler machine.The equipment is challenged at the beginning of the shift.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.Probable root cause, the plunger rod labeler machine.This is an escape from the plunger rod labeler machine.H3 other text : see h.10.

• Brand Name: SYRINGE 5ML HEPARIN 100 UNIT
• Common Device Name: HEPARIN
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY; 2153 12th avenue; columbus NE 68601
• MDR Report Key: 8931509
• Report Number: 1911916-2019-00859
• Device Sequence Number: 514305
• 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: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2019

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 Catalogue Number: 306424
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• 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: 09/30/2019
• 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