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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD¿ CATHETER
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BECTON DICKINSON UNSPECIFIED BD¿ CATHETER Back to Search Results
Catalog Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Bacterial Infection (1735); Skin Irritation (2076)
Event Date 07/30/2019
Event Type  malfunction  
Manufacturer Narrative
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 (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
 
Event Description
It was reported that unspecified bd¿ catheter was used and caused irritations.This occurred on 6 occasions during use.No date/time or patient information was given.The following information was provided by the initial reporter: during my follow-up, in the presence of the pharmacist we saw 6 residents with skin disorders such as abscesses, including a necrotizing dermohypodermatitis infected with staph aureus doré, which will soon have to be operated on.A second collection on another resident was made yesterday, awaiting the result.No events had been reported so far.Nurses linked these events to the placement of a sc safe t intima catheter.Skin signs (redness and induration) appeared for some, 24 hours after application.These events have occurred over the past month, on patients in a generally fragile state.During the interview, the nurses acknowledged that they did not perform the skin antisepsis protocol before insertion as recommended by the hospital hygiene team (1 time alcoholic betadine versus 5 times betadine).However, they say they removed the catheters immediately after the first signs of infection.
 
Manufacturer Narrative
H.6.Investigation summary: a lot number could not be connected to the device identified in the complaint, bd investigators could not conduct a device history review for this event.Additionally, a sample was not submitted for evaluation and testing, preventing bd engineers from conducting a full investigation and determining a root cause.H3 other text : see section h.10.
 
Event Description
It was reported that unspecified bd¿ catheter was used and caused irritations.This occurred on 6 occasions during use.No date/time or patient information was given.The following information was provided by the initial reporter: during my follow-up, in the presence of the pharmacist we saw 6 residents with skin disorders such as abscesses, including a necrotizing dermohypodermatitis infected with staph aureus doré, which will soon have to be operated on.A second collection on another resident was made yesterday, awaiting the result.No events had been reported so far.Nurses linked these events to the placement of a sc safe t intima catheter.Skin signs (redness and induration) appeared for some, 24 hours after application.These events have occurred over the past month, on patients in a generally fragile state.During the interview, the nurses acknowledged that they did not perform the skin antisepsis protocol before insertion as recommended by the hospital hygiene team (1 time alcoholic betadine versus 5 times betadine).However, they say they removed the catheters immediately after the first signs of infection.
 
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Brand Name
UNSPECIFIED BD¿ CATHETER
Type of Device
CATHETER
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key8895795
MDR Text Key154721513
Report Number2243072-2019-01708
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 08/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Initial Date Manufacturer Received 07/30/2019
Initial Date FDA Received08/14/2019
Supplement Dates Manufacturer Received07/30/2019
Supplement Dates FDA Received08/27/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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