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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD ORAL DISPENSING SYRINGE; LIQUID MEDICATION DISPENSER
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BECTON DICKINSON MEDICAL SYSTEMS BD ORAL DISPENSING SYRINGE; LIQUID MEDICATION DISPENSER Back to Search Results
Catalog Number 305217
Device Problem Volume Accuracy Problem (1675)
Patient Problem No Patient Involvement (2645)
Event Date 08/05/2020
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date: n/a.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
 
Event Description
It was reported that the scale markings on the bd¿ oral dispensing syringe were misaligned starting at the zero indicator.This was found before use.The following information was provided by the initial reporter: "while reviewing some of the pediatric oral syringe preparations it came to my attention that the zero line/indicator on the bd 1 ml syringes appear to be printed slightly on several of the syringes.I am unsure if it affecting the subsequent volume indicators (e.G., 0.1; 0.2; 03; etc) as you progress on the syringe.There were a couple of examples where it did appear that some of the volume indication lines were effected.".
 
Event Description
It was reported that the scale markings on the bd¿ oral dispensing syringe were misaligned starting at the zero indicator.This was found before use.The following information was provided by the initial reporter: "while reviewing some of the pediatric oral syringe preparations it came to my attention that the zero line/indicator on the bd 1 ml syringes appear to be printed slightly on several of the syringes.I am unsure if it affecting the subsequent volume indicators (e.G., 0.1; 0.2; 03; etc) as you progress on the syringe.There were a couple of examples where it did appear that some of the volume indication lines were effected.".
 
Manufacturer Narrative
H.6.Investigation summary: one photo and three loose 1ml oral syringes were received in a zip lock bag.The photo depicted a full bag of 1ml oral syringes with no indication of defects observed.The received samples were visually evaluated.Two of the samples had indications of prior manipulation and contamination with unidentified clear liquid in the fluid path, as well attached tip caps.The two syringes were observed to have a skew to the zero line ¿ it was printed at a slight angle.However, it was at the correct location at the bottom of the barrel and did not appear to have any effect on volumetric accuracy.No defects were observed to be present in the rest of the printed scale markings.One syringe appeared to have been unused.It had no visible scale marking defects.Due to unknown contamination of the two capped samples, no additional evaluation or testing could be performed.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.H3 other text : see h.10.
 
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Brand Name
BD ORAL DISPENSING SYRINGE
Type of Device
LIQUID MEDICATION DISPENSER
Manufacturer (Section D)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
MDR Report Key10434284
MDR Text Key204403690
Report Number1213809-2020-00565
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 health professional,other,use
Type of Report Initial,Followup
Report Date 09/02/2020
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
Device Operator Other
Device Catalogue Number305217
Device Lot Number0027795
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/12/2020
Initial Date Manufacturer Received 08/05/2020
Initial Date FDA Received08/20/2020
Supplement Dates Manufacturer Received08/05/2020
Supplement Dates FDA Received09/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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