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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE ORAL 3ML AMBER; LIQUID MEDICATION DISPENSER
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BECTON DICKINSON MEDICAL SYSTEMS SYRINGE ORAL 3ML AMBER; LIQUID MEDICATION DISPENSER Back to Search Results
Catalog Number 305210
Device Problems Device Markings/Labelling Problem (2911); Illegible Information (4050)
Patient Problem No Patient Involvement (2645)
Event Date 10/24/2019
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that an unspecified number of syringe oral 3ml amber experienced label or package smeared/print permanency illegible, and no label or missing label information which was noted prior to use.The following information was provided by the initial reporter: on inspection of a recent delivery, 4 boxes has missing lot numbers on the external label (the individual bags were labelled) and 1 box had a label that was damaged and unreadable.The syringes are usable so we are not looking to return these, but wanted to make you aware of this issue so you can investigate this internally.
 
Event Description
It was reported that an unspecified number of syringe oral 3ml amber experienced label or package smeared/print permanency illegible, and no label or missing label information which was noted prior to use.The following information was provided by the initial reporter: on inspection of a recent delivery, 4 boxes has missing lot numbers on the external label (the individual bags were labelled) and 1 box had a label that was damaged and unreadable.The syringes are usable so we are not looking to return these, but wanted to make you aware of this issue so you can investigate this internally.
 
Manufacturer Narrative
H.6.Investigation summary: three photos were received and evaluated.One photo displayed a 500-count label (p/n 305210) with no batch number listed.One photo displayed a blank side of a box.One photo displayed a damaged label with a portion of the bar code and batch number scratched off with only ending numbers ¿24703¿ visible.The missing label and content were rejectable per product specification.The damaged label defect cannot be confirmed.From the photo provided it was unclear how the damage occurred or if there was additional damage present on the box.The potential root causes for the missing label and missing batch information are associated with packaging process and a gap in procedure.1) if a box does not get labelled at the printer, then the label would have to be applied manually.Due to the printer fail safe, it does not allow blank labels to be printed which indicates the labels were placed on by hand.2) during the manufacture of this batch there was no procedure in place to verify label presence or content.Action taken: 1) accountability actions will be taken for the associate involved by 1/1/2020.2) the procedure for this packaging machine was revised to include verifying the label presence and content, and all associates on this machine were retrained as of 4/9/2019.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.H3 other text : see section h.10.
 
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Brand Name
SYRINGE ORAL 3ML AMBER
Type of Device
LIQUID MEDICATION DISPENSER
Manufacturer (Section D)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
MDR Report Key9297240
MDR Text Key197344947
Report Number1213809-2019-01122
Device Sequence Number1
Product Code KYW
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,other
Type of Report Initial,Followup
Report Date 12/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number305210
Device Lot Number9024703
Date Manufacturer Received10/24/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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