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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD¿ POSIFLUSH¿ SALINE XS 10 ML; SALINE, VASCULAR ACCESS FLUSH
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BECTON, DICKINSON AND CO. BD¿ POSIFLUSH¿ SALINE XS 10 ML; SALINE, VASCULAR ACCESS FLUSH Back to Search Results
Catalog Number 306572
Device Problem Contamination (1120)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/20/2023
Event Type  malfunction  
Event Description
It was reported while using bd¿ posiflush¿ saline xs 10 ml foreign matter was found.There was no report of patient impact.The following information was provided by the initial reporter: the customer has observed foreign contamination with two lot numbers of this flush syringe.Foreign matter can be seen on the outside and inside of the syringes.Because the customer cannot flush their port, they have been unable to administer their medication.This has resulted in mental and physical distress.No serious injuries were reported.Initial occurrence date: (b)(6) 2023.
 
Manufacturer Narrative
There were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: d4.Medical device lot #: 2293101.D4.Medical device expiration date: 30sep2025.H4.Device manufacture date: 20oct2022.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It was reported while using bd¿ posiflush¿ saline xs 10 ml foreign matter was found.There was no report of patient impact.The following information was provided by the initial reporter: the customer has observed foreign contamination with two lot numbers of this flush syringe.Foreign matter can be seen on the outside and inside of the syringes.Because the customer cannot flush their port, they have been unable to administer their medication.This has resulted in mental and physical distress.No serious injuries were reported.Initial occurrence date: 20apr23.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 01-june-2023 h6: investigation summary a device history record review was completed for provided material number 306572 and lot numbers 2153822 and 2293101.The review did not reveal any possible non-conformances during the production process that could have contributed to the reported incident.To aid in the investigation of this issue, fifteen (15) picture samples and seventy-six (76) physical samples were returned for evaluation by our investigative team.Through examination of the samples, foreign particles were identified.The foreign material observed on the syringes appeared to be resulting from fiber tears.A small amount of fiber tear naturally occurs when separating individual blister packages and also when separating the paper top web from the plastic bottom web.
 
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Brand Name
BD¿ POSIFLUSH¿ SALINE XS 10 ML
Type of Device
SALINE, VASCULAR ACCESS FLUSH
Manufacturer (Section D)
BECTON, DICKINSON AND CO.
donore road
drogheda
Manufacturer (Section G)
BECTON, DICKINSON AND CO.
donore road
drogheda
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8448235433
MDR Report Key16989526
MDR Text Key316631927
Report Number1213809-2023-00556
Device Sequence Number1
Product Code NGT
UDI-Device Identifier00382903065721
UDI-Public(01)00382903065721
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 07/05/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/23/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number306572
Device Lot Number2153822
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received07/05/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/02/2022
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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