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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ NORMAL SALINE SYRINGE; SALINE VASCULAR ACCESS FLUSH
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BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ NORMAL SALINE SYRINGE; SALINE VASCULAR ACCESS FLUSH Back to Search Results
Catalog Number 306595
Device Problem Volume Accuracy Problem (1675)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/26/2021
Event Type  malfunction  
Manufacturer Narrative
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 scale markings were illegible with 3 bd posiflush¿ normal saline syringes.The following information was provided by the initial reporter, translated from chinese to english: when the nurse in the department of cardiology of hospital opened the package, she found a large area of marker daub inside the package.The customer was anxious to give an answer and hoped to solve the problem as soon as possible.Additionally on (b)(6) 2021 received update from sales representative, event description updated as follows: a problem that occurs in a clean package when the package is not opened.
 
Manufacturer Narrative
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 scale markings were illegible with 3 bd posiflush¿ normal saline syringes.The following information was provided by the initial reporter, translated from chinese to english: when the nurse in the department of cardiology of hospital opened the package, she found a large area of marker daub inside the package.The customer was anxious to give an answer and hoped to solve the problem as soon as possible.Additionally on (b)(6) 2021 received update from sales representative, event description updated as follows: a problem that occurs in a clean package when the package is not opened.
 
Event Description
It was reported that the scale markings were illegible with 3 bd posiflush¿ normal saline syringes.The following information was provided by the initial reporter, translated from chinese to english: when the nurse in the department of cardiology of hospital opened the package, she found a large area of marker daub inside the package.The customer was anxious to give an answer and hoped to solve the problem as soon as possible.Additionally on 2021-10-28 received update from sales representative, event description updated as follows: a problem that occurs in a clean package when the package is not opened.
 
Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 12/17/2021.H.6.Investigation: it was reported the customer found a large area of marker daub inside the package.To aid in the investigation, one empty sample with no packaging flow wrap and one photo was provided for evaluation by our quality team.A visual inspection was performed and the syringe barrel has lines drawn with a black marker where the scale is.No other defects or imperfections were observed.The photo provided shows the sample received.It could be possible the equipment sensors were challenged using this sample and during that verification process the sample moved into the next processes without being detected.A device history record review was completed for provided material number 306595, lot number 1046875.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.To date, there have been no other similar events reported for this lot.Based on the investigation and with the returned sample analysis the symptom reported by the customer is confirmed.
 
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Brand Name
BD POSIFLUSH¿ NORMAL SALINE SYRINGE
Type of Device
SALINE VASCULAR ACCESS FLUSH
Manufacturer (Section D)
BD MEDICAL (BD WEST) MEDICAL SURGICAL
1852 10th avenue
columbus NE 68601
Manufacturer (Section G)
BD MEDICAL (BD WEST) MEDICAL SURGICAL
1852 10th avenue
columbus NE 68601
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12861980
MDR Text Key285568232
Report Number1911916-2021-01182
Device Sequence Number1
Product Code NGT
Combination Product (y/n)N
Reporter Country CodeCH
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 01/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/31/2024
Device Catalogue Number306595
Device Lot Number1046875
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/17/2021
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/26/2021
Initial Date FDA Received11/23/2021
Supplement Dates Manufacturer Received01/05/2022
Supplement Dates FDA Received01/13/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/15/2021
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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