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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 No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/18/2022
Event Type  malfunction  
Event Description
It was reported that 30 bd posiflush¿ pre-filled saline syringes experienced device damage while still considered operable.The following information was provided by the initial reporter: we received a box of 30 bd posiflush 10ml syringes that were broken.It is not possible to push nacl out of syringes.
 
Manufacturer Narrative
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 have been updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 08-feb-2023.H.6.Investigation summary: to aid in the investigation of this issue, five (5) physical samples were returned for evaluation by our quality engineer team.Four (4) of the samples were still in their unit packages and one (1) sample appeared to have been used.A silicone distribution test was performed on all of the returned samples.All of the samples tested correctly for silicone distribution.The syringe that appeared used showed correct silicone distribution; however, a lighter quantity was observed, which could have contributed to resistance when moving the plunger; therefore, the reported issue is confirmed.A device history record review was completed for provided material number 306575 and lot number 2263053.The review did not reveal any quality notifications during the production process; however, there were two (2) second samplings that could have potentially been related to this reported incident.Although all inspections were found to be within specifications, a corrective maintenance was carried out on the fill machines where the nozzle and the sleeve pump were replaced.It has been determined that the defective sample was most likely manufactured somewhere between the second samplings during the production process.Based on the preventive measures in place, we believe this was an isolated incident with an unlikely chance of recurrence.At this time, further action has not been determined necessary.Our quality team will continue to closely monitor the manufacturing process for signs of this potential defect and any emerging trends.H3.Other text : see h10.
 
Event Description
It was reported that 30 bd posiflush¿ pre-filled saline syringes experienced device damage while still considered operable.The following information was provided by the initial reporter: we received a box of 30 bd posiflush 10ml syringes that were broken.It is not possible to push nacl out of syringes.
 
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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 Key15955966
MDR Text Key308173475
Report Number3002682307-2022-00335
Device Sequence Number1
Product Code NGT
Combination Product (y/n)N
Reporter Country CodeSW
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 04/11/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number306575
Device Lot Number2263053
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/11/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/20/2022
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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