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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON BD POSIFLUSH-SAFESCRUB 10 ML (US/CA); SALINE, VASCULAR ACCESS FLUSH

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BECTON DICKINSON BD POSIFLUSH-SAFESCRUB 10 ML (US/CA); SALINE, VASCULAR ACCESS FLUSH Back to Search Results
Catalog Number 303191
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/29/2024
Event Type  malfunction  
Manufacturer Narrative
(b)(4): initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.H3 other text : see h10 manufacture narrative.
 
Event Description
Material#: unknown lot#: 7ju6x1711 it was reported by the customer that the safe scrub that she saved with what appears to have rust(?) on the inside of the packaging.Verbatim: i wanted to forward this along ¿ a staff nurse had brought a safescrub that she saved with what appears to have rust(?) on the inside of the packaging.She said that to her knowledge, the safescrub was completely sealed and covered at the time she removed the top foil.I told her i¿d pass along.She is the first that has brought this up so i¿m thinking this is a one-off, but wanted to bring to your attention.Thanks!.
 
Manufacturer Narrative
(b)(4) - follow up mdr for additional information received by sale's rep on 28march2024: batch number confirmed.Section d2: common device name updated, pro code updated.Section d4: batch number updated.Section g4: 510k updated.
 
Event Description
Material number and batch confirmed by sales rep.
 
Manufacturer Narrative
(b)(4) follow up for device evaluation it was reported the safescrub has what appears to be rust inside the packaging.To aid in the investigation, one sample with no packaging flow wrap and two photos were provided for evaluation by our quality team.The disinfecting unit has the top web removed and loose.The unit top and top web have a brown discoloration.The two photos provided show the sample received.The sample was sent to the site that manufactures the disinfecting unit for an additional investigation.The sample received at the site had traces of possible brown oxidation in the cap and foil.Per their report, this defect could occur during the sterilization of the product.A device history record review was completed for provided material number 303191, lot 2314320.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.There were no related quality notifications.All processes and final inspections complied with specification requirements.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.
 
Event Description
No additional information received material#: unknown lot#: 7ju6x1711 it was reported by the customer that the safe scrub that she saved with what appears to have rust(?) on the inside of the packaging.Verbatim: i wanted to forward this along ¿ a staff nurse had brought a safescrub that she saved with what appears to have rust(?) on the inside of the packaging.She said that to her knowledge, the safescrub was completely sealed and covered at the time she removed the top foil.I told her i¿d pass along.She is the first that has brought this up so i¿m thinking this is a one-off, but wanted to bring to your attention.Thanks!.
 
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Brand Name
BD POSIFLUSH-SAFESCRUB 10 ML (US/CA)
Type of Device
SALINE, VASCULAR ACCESS FLUSH
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer (Section G)
BD MEDICAL (BD WEST) MEDICAL SURGICAL
1852 10th avenue
columbus NE 68601
Manufacturer Contact
helen cox (mdr)
75 north fairway drive
vernon hills, IL 60061
8473935694
MDR Report Key18988009
MDR Text Key338764407
Report Number1911916-2024-00218
Device Sequence Number1
Product Code NGT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K213955
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 05/14/2024
2 Devices were Involved in the Event: 1   2  
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 Catalogue Number303191
Device Lot NumberUNKNOWN
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/29/2024
Initial Date FDA Received03/27/2024
Supplement Dates Manufacturer Received03/28/2024
05/14/2024
Supplement Dates FDA Received03/28/2024
05/14/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/10/2022
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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