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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE; SALINE, VASCULAR ACCESS FLUSH
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BECTON DICKINSON, S.A. BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE; SALINE, VASCULAR ACCESS FLUSH Back to Search Results
Catalog Number 306575
Device Problem Break (1069)
Patient Problem Pain (1994)
Event Date 11/03/2022
Event Type  malfunction  
Event Description
It was reported that at least 2 bd posiflush¿ pre-filled saline syringes experienced a broken tip.The following information was provided by the initial reporter: on 1 day, 2 syringes broke off when disconnecting the syringe, (off the three-way valve).Other colleagues reported that this had happened more often in recent weeks.
 
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.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 01-mar-2023.H6: investigation summary.A device history record review was completed for provided material number 306575 and lot number 2208773.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported defect and all quality tests were found to be within specification.To aid in the investigation of this issue, the affected sample was returned for evaluation by our quality engineer team.Through examination of the sample, the syringe was found without a tip and signs of a clean break, confirming the reported defect.However, this type of breakage is not produced during the manufacturing process.All manufacturing records for this lot show that the product met the operation parameters with no signs of molding issues.Per the provided feedback, the syringe was used with no issues and then the tip broke after 3-way valve disconnection.Once used, the syringe should be disconnected by unscrewing completely; never pull or bend the syringe as the tip could break as a result.This is a very unusual circumstance.The barrel tip and luer lock components are inspected at the molding area and tip cap assembly areas as part of our quality procedures.
 
Event Description
It was reported that at least 2 bd posiflush¿ pre-filled saline syringes experienced a broken tip.The following information was provided by the initial reporter: on 1 day, 2 syringes broke off when disconnecting the syringe, (off the three-way valve).Other colleagues reported that this had happened more often in recent weeks.
 
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Brand Name
BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE
Type of Device
SALINE, VASCULAR ACCESS FLUSH
Manufacturer (Section D)
BECTON DICKINSON, S.A.
cr mequinenza
s/n
fraga, huesca 22520
SP  22520
Manufacturer (Section G)
BECTON DICKINSON, S.A.
cr mequinenza
s/n
fraga, huesca 22520
SP   22520
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key15888743
MDR Text Key307097362
Report Number3002682307-2022-00314
Device Sequence Number1
Product Code NGT
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/10/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/30/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number306575
Device Lot Number2208773
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/20/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/27/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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