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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD TUBING; INTRAVASCULAR ADMINISTRATION SET
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BECTON DICKINSON UNSPECIFIED BD TUBING; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number UNKNOWN
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/01/2020
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Unknown manufacturer: (b)(4).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.(b)(4).
 
Event Description
It was reported that unspecified bd¿ tubing was missing the clamp.The following information was provided by the initial reporter: material no: unknown batch no: unknown.Event 1: it was reported that the first tubing had no clamp.Event 2: it was reported that the second tubing had no way to connect the tubing to the luer lock on the sister tubing because there was no part to screw onto the other tubing.Event 3: it was reported that the third tubing disconnected at the gtt chamber while priming the tubing.Event 4: it was reported that another disconnected at the y-site after priming.Event 5: it was reported that the positive pressure port has nothing around the blue part (clear surrounding piece is gone).Verbatim: are you able to provide details on the reported failure? the first tubing had no clamp.Second tubing hand no way to connect the tubing to the leur lock on the sister tubing, there was no part to screw onto the other tubing.Third the tubing disconnected at the gtt chamber while priming the tubing, another disconnected at the y site, after priming.I have one that the positive pressure port has nothing around the blue part(clear surrounding piece is gone.) was there any adverse event(s) as a result of the reported defect? o if yes, please provide details, in addition to patient identifiers (initials, sex, dob, diagnosis, etc.).I do believe that this has caused issues with getting medication to the patients but will have to verify.
 
Manufacturer Narrative
H.6.Investigation: one sample was received for quality investigation.The customer complaint of the tubing disconnected at the y-site after priming, misassembly, and drip chamber separating from the tubing, was verified by visual inspection.A device history record review could not be performed because a model or lot number was not provided by the customer.The root cause for the issues observed with this sample is a manufacturing error during assembly.
 
Event Description
It was reported that unspecified bd¿ tubing was missing the clamp.The following information was provided by the initial reporter: material no: unknown batch no: unknown.Event 1: it was reported that the first tubing had no clamp.Event 2: it was reported that the second tubing had no way to connect the tubing to the luer lock on the sister tubing because there was no part to screw onto the other tubing.Event 3: it was reported that the third tubing disconnected at the gtt chamber while priming the tubing.Event 4: it was reported that another disconnected at the y-site after priming.Event 5: it was reported that the positive pressure port has nothing around the blue part (clear surrounding piece is gone).Verbatim: are you able to provide details on the reported failure? the first tubing had no clamp.Second tubing hand no way to connect the tubing to the leur lock on the sister tubing, there was no part to screw onto the other tubing.Third the tubing disconnected at the gtt chamber while priming the tubing, another disconnected at the y site, after priming.I have one that the positive pressure port has nothing around the blue part(clear surrounding piece is gone.) was there any adverse event(s) as a result of the reported defect? o if yes, please provide details, in addition to patient identifiers (initials, sex, dob, diagnosis, etc.).I do believe that this has caused issues with getting medication to the patients but will have to verify.
 
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Brand Name
UNSPECIFIED BD TUBING
Type of Device
INTRAVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key11098189
MDR Text Key228237555
Report Number2243072-2020-02197
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 01/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/10/2020
Date Manufacturer Received01/07/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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