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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. SYRINGE 10ML REG PR SALINE FILL SPKG; INTRAVASCULAR CATHETER
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BECTON, DICKINSON AND CO. SYRINGE 10ML REG PR SALINE FILL SPKG; INTRAVASCULAR CATHETER Back to Search Results
Model Number 306553
Device Problem Volume Accuracy Problem (1675)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/26/2020
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: a device history record review was performed for provided lot number 9127571 and the review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.As neither a physical sample nor a picture sample was available for return, our quality engineer team was unable to complete a thorough sample investigation.As the reported defect could not be confirmed and there is no history of related complaints for this lot number, a cause for this incident could not be determined.Our quality team will continue to monitor the production process for signs of this potential defect and any emerging trends.Investigation conclusion: material no.: 306553 batch no.: 9127571.The non-conformance's were reviewed for this batch and there was no record of non-conformance associated with this batch.There were no samples or photos returned.Based on the investigation, the root cause of this complaint could not be substantiated as there were no photos or samples returned.Root cause description: based on the investigation, the root cause of this complaint could not be substantiated as there were no photos or samples returned.
 
Event Description
It was reported that scale marking issue was found before use with a syringe 10ml reg pr saline fill spkg.The following information was provided by the initial reporter, "i want to make you aware that we found some 306553 from lot# 9127571 that are blank, missing any information or markings.I have attached an image for your reference.So far we have went through a little over 1,000 pieces and found only 3 pieces affected.We still have about 8,000 pieces of this lot left in stock so i will keep you posted if/as we find them." 3 occurrences were reported.
 
Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 4/17/2020.H.6.Investigation: a device history record review was performed for provided lot number 9127571 and the review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.To aid in the investigation of this issue, three physical samples were returned for evaluation by our quality engineer team.Through examination of the samples, the scale markings were observed missing.It has been determined that this incident resulted from an error in the vision system machine.The camera of the vision system should detect faulty product before release; however, an error occurred within the vision detection system which prevented this defective product from being discarded.In response to this incident, the vision system was cleaned and the camera lens was refocused.Sample syringes with no labels were sent through the vision system as a test and the vision system properly rejected the defective samples.
 
Event Description
It was reported that scale marking issue was found before use with a syringe 10ml reg pr saline fill spkg.The following information was provided by the initial reporter, "i want to make you aware that we found some 306553 from lot# 9127571 that are blank, missing any information or markings.I have attached an image for your reference.So far we have went through a little over 1,000 pieces and found only 3 pieces affected.We still have about 8,000 pieces of this lot left in stock so i will keep you posted if/as we find them." 3 occurrences were reported.
 
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Brand Name
SYRINGE 10ML REG PR SALINE FILL SPKG
Type of Device
INTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON, DICKINSON AND CO.
donore road
drogheda
MDR Report Key9981372
MDR Text Key193281691
Report Number9616657-2020-00062
Device Sequence Number1
Product Code NGT
UDI-Device Identifier30382903065531
UDI-Public30382903065531
Combination Product (y/n)N
PMA/PMN Number
K153481
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,other
Type of Report Initial,Followup
Report Date 04/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date04/30/2022
Device Model Number306553
Device Catalogue Number306553
Device Lot Number9127571
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/17/2020
Date Manufacturer Received03/31/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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