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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. UNSPECIFIED BD CATHETER; INTERVASCULAR CATHETER

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BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. UNSPECIFIED BD CATHETER; INTERVASCULAR CATHETER Back to Search Results
Catalog Number UNKNOWN
Device Problem Leak/Splash (1354)
Patient Problem Blood Loss (2597)
Event Date 07/23/2019
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 intima-ii 22 ga x 0.75 in prn slm experienced leakage during use.The following information was provided by the initial reporter: it's noticed that blood leakage at the connection site between ext.Tubing and catheter junction.
 
Manufacturer Narrative
Investigation: unfortunately a lot number could not be submitted for this complaint, and could not be determined from the photographs provided.Preventing our investigation team from conducting a device history review.Additionally leakage testing of the returned device was able to identify a small breach in the catheter tubing that resulted in the observed leak.A review of our manufacturing determined that the damage to the catheter tubing could not have been sustained during the manufacturing process, because of the dimensions of the wound.Unfortunately, the root cause for this complaint could not be determined at the conclusion of our review.
 
Event Description
It was reported that the unspecified bd catheter experienced leakage during use.The following information was provided by the initial reporter: it's noticed that blood leakage at the connection site between ext.Tubing and catheter junction.
 
Manufacturer Narrative
The following information has been updated: b.5.Describe event or problem: it was reported that the unspecified bd catheter experienced leakage during use.The following information was provided by the initial reporter: it's noticed that blood leakage at the connection site between ext.Tubing and catheter junction.D.1.Medical device brand name: unspecified bd catheter.D.4.Medical device catalog #: unknown.D.4.Medical device lot #: unknown.D.4 device expiration date: unknown.D.4.Unique identifier (udi) #: unknown.G.5.Pma/510(k)#: unknown.H.4.Device manufacture date: unknown h3 other text: see h.10.
 
Event Description
It was reported that the unspecified bd catheter experienced leakage during use.The following information was provided by the initial reporter: it's noticed that blood leakage at the connection site between ext.Tubing and catheter junction.
 
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Brand Name
UNSPECIFIED BD CATHETER
Type of Device
INTERVASCULAR CATHETER
Manufacturer (Section D)
BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
9 rui pu road export zone b
suzhou
MDR Report Key8899314
MDR Text Key155975438
Report Number3006948883-2019-00658
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup,Followup
Report Date 09/12/2019
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 Other
Device Expiration Date06/12/2021
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/10/2019
Initial Date Manufacturer Received 07/31/2019
Initial Date FDA Received08/15/2019
Supplement Dates Manufacturer Received07/31/2019
07/31/2019
Supplement Dates FDA Received08/21/2019
09/12/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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