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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD¿ CATHETER TIP SYRINGE; IRRIGATING SYRINGE
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BD MEDICAL (BD WEST) MEDICAL SURGICAL BD¿ CATHETER TIP SYRINGE; IRRIGATING SYRINGE Back to Search Results
Catalog Number 309620
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/28/2019
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 the incorrect catalog number was found on the box of bd¿ catheter tip syringes before use.The following information was provided by the initial reporter: "we received these in this week.Notice the manufacturer catalog number it is the same on both boxes but these are 2 different items.".
 
Manufacturer Narrative
Investigation summary: no samples or photos were provided by the customer for investigation.A device history record (dhr) review was performed on the batch associated with this investigation.The dhr reviews did not reveal any defects or issues reported and no quality notifications were issued.Conclusion: the change in scale mark from 60 ml to 50 ml was an intentional change, and not a non-conformance.Bd has made a business decision to move from 60 ml syringes to 50 ml syringes based on the following reasons: 1.Help drive safe sterile compounding practice by preventing overfill of medications and complying with aseptic technique.2.Standardize the bd® large volume syringe offering a better manage market supply and mitigate the risk of product shortages resulting from market related events.3.Align with other medication receptacles that may be in short supply (i.E.50 ml mini bags, 50% dextrose prefilled syringe, sodium bicarbonate prefilled syringe, ect.) to facilitate product substitution with no anticipated clinical impact.Prior to changing the product to 50 ml, notifications were sent to the customers about the upcoming change.The letter, which was dated august 26, 2019, specifies that 50 ml syringes could arrive at facilities october and december 2019.
 
Event Description
It was reported that the incorrect catalog number was found on the box of bd¿ catheter tip syringes before use.The following information was provided by the initial reporter: "we received these in this week.Notice the manufacturer catalog number it is the same on both boxes but these are 2 different items.".
 
Event Description
It was reported that the incorrect catalog number was found on the box of bd¿ catheter tip syringes before use.The following information was provided by the initial reporter: "we received these in this week.Notice the manufacturer catalog number it is the same on both boxes but these are 2 different items".
 
Manufacturer Narrative
Mfr# 1911916-2019-01193 has been deemed not reportable after further review and will be cancelled.There was no report of serious injury, medical intervention, or reportable device malfunction.General dissatisfaction of the product does not impact the intended use of the device which would not lead to harm or serious injury to the clinician or patient.As a result mfr# 1911916-2019-01193 is null and void.
 
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Brand Name
BD¿ CATHETER TIP SYRINGE
Type of Device
IRRIGATING SYRINGE
Manufacturer (Section D)
BD MEDICAL (BD WEST) MEDICAL SURGICAL
1852 10th avenue
columbus NE 68601
MDR Report Key9310262
MDR Text Key194601877
Report Number1911916-2019-01193
Device Sequence Number1
Product Code KYZ
UDI-Device Identifier30382903096207
UDI-Public30382903096207
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,other
Type of Report Initial,Followup,Followup
Report Date 12/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number309620
Device Lot Number9207632
Was Device Available for Evaluation? No
Date Manufacturer Received10/28/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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