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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD¿ PERISAFE I ANESTHESIA KIT 16 X 3-1/2IN

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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD¿ PERISAFE I ANESTHESIA KIT 16 X 3-1/2IN Back to Search Results
Catalog Number 400679
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/05/2018
Event Type  malfunction  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that bd¿ perisafe i anesthesia kit 16 x 3-1/2in was missing label information. No serious injury or medical intervention was reported.
 
Manufacturer Narrative
Dhr for lot number 8008626 was reviewed and no qns or other events were related to the complaint stated by the customer. Material (b)(4) with lot number 8008626 was manufactured on (b)(6) 2018. According to sampling plan applied, this lot was accepted without any defect or deviation. During this lot, 125 samples were inspected visually during the final audit without found any defect the inspection is performed by qa tech on final inspection of the kit. The epidural catheter it is received from external supplier during the process only the outside diameter is verified 100% tread assist is installed into epidural catheter, at raw material receipt a random sampling is taken to perform visual inspection by missing marks on the tip formed end, on reported batch the following batches of epidural catheter 115370273mex were used 73f1700294, 73d1700462, 73d1700463, & 73f1700086 all of these lots were received without found any defect at incoming inspection. Manufacturing process was reviewed and no potential failure modes were found. No sample or photos were provided to perform sample evaluation. All relevant information during the dhr review shown that meet all established manufacturing criteria. We could not determine the root cause and cannot confirm the issue stated by the customer due that no samples/photos were sent for evaluation.
 
Event Description
It was reported that bd perisafe i anesthesia kit 16 x 3-1/2in was missing label information. No serious injury or medical intervention was reported.
 
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Brand NameBD¿ PERISAFE I ANESTHESIA KIT 16 X 3-1/2IN
Type of DeviceANESTHESIA KIT
Manufacturer (Section D)
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
periferico luis donaldo
colosio no. 579
nogales
MDR Report Key8061120
MDR Text Key127075969
Report Number9610847-2018-00391
Device Sequence Number1
Product Code CAZ
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 12/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number400679
Device Lot Number8008626
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/05/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 11/12/2018 Patient Sequence Number: 1
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