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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON BD POSIFLUSH¿ NORMAL SALINE SYRINGE; SALINE, VASCULAR ACCESS FLUSH

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BECTON DICKINSON BD POSIFLUSH¿ NORMAL SALINE SYRINGE; SALINE, VASCULAR ACCESS FLUSH Back to Search Results
Catalog Number 306572
Device Problem Missing Information (4053)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/31/2023
Event Type  malfunction  
Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in sections d.3.And g.1.And the franklin lakes fda registration number has been used for the manufacture report number.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.H3.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 6 cases of the bd posiflush¿ normal saline syringe don't have labels on the boxes.The following was received by the customer: customer reported 6 cases of the (b)(4), which doesn't have label on the box so we cannot sell it to their customers.
 
Manufacturer Narrative
The following fields have been updated due to additional information: device available for eval?: yes returned to manufacturer on: 30-aug-2023 investigation summary: a device history record review was completed for provided material number 306572 and lot number 2188694 (obtained from the provided samples).There were no detected non-conformances during the production process that could have contributed to this reported incident.To aid in the investigation of this issue, a shipment case containing eight (8) shelf cartons was returned for evaluation by our quality team.Through inspection of the samples, six (6) shelf cartons were found without shelf carton labels.The missing labels most likely resulted from a glitch in the vision system.Since the manufacture of this lot, a correction has been implemented to prevent this issue from recurring.Operators are required to complete a start of shift challenge for the vision system, in order to ensure the system is working correctly.Our quality team will continue to closely monitor the manufacturing process for signs of this potential defect and any emerging trends.
 
Event Description
It was reported that 6 cases of the bd posiflush¿ normal saline syringe don't have labels on the boxes.The following was received by the customer: customer reported 6 cases of the 306572 which doesn't have label on the box so we cannot sell it to their customers.
 
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Brand Name
BD POSIFLUSH¿ NORMAL SALINE SYRINGE
Type of Device
SALINE, VASCULAR ACCESS FLUSH
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer (Section G)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer Contact
jennifer suh
5859 farinon drive
san antonio, TX 78249
8448235433
MDR Report Key17537643
MDR Text Key321726550
Report Number2243072-2023-01435
Device Sequence Number1
Product Code NGT
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,Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/12/2023
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 Other
Device Catalogue Number306572
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/31/2023
Initial Date FDA Received08/12/2023
Supplement Dates Manufacturer Received10/12/2023
Supplement Dates FDA Received10/20/2023
Was Device Evaluated by Manufacturer? Yes
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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