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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. PERISAFE I 17 X 3-1/2IN; CATHETER
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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. PERISAFE I 17 X 3-1/2IN; CATHETER Back to Search Results
Catalog Number 405067
Device Problems Leak/Splash (1354); Device Markings/Labelling Problem (2911)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/30/2019
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 perisafe i 17 x 3-1/2in had holes in the catheter and was missing label information.This occurred on 7 occasions during use.The following information was provided by the initial reporter: (1) anesthesia equipment without permeable lumen to pass medication, probably due to the lack of holes in the distal catheter.(2) of seven inspected primary containers, none presents the instructions for conservation.(3) of seven inspected parts, no filter is present.(4) of five inspected parts, no filter is present.
 
Manufacturer Narrative
H.6.Investigation: although a sample was in transit for this incident, our facility was unable to retrieve the sample due to covid-19 restrictions.A device history record review was performed for provided lot number 9025676 and the review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.Based on the investigation results, a cause for the reported incident could not be determined and the incident could not be confirmed.H3 other text : see h.10.
 
Event Description
It was reported that perisafe i 17 x 3-1/2in had holes in the catheter and was missing label information.This occurred on 7 occasions during use.The following information was provided by the initial reporter: (1) anesthesia equipment without permeable lumen to pass medication, probably due to the lack of holes in the distal catheter.(2) of seven inspected primary containers, none presents the instructions for conservation.(3) of seven inspected parts, no filter is present.(4) of five inspected parts, no filter is present.
 
Event Description
It was reported that perisafe i 17 x 3-1/2in had holes in the catheter and was missing label information.This occurred on 7 occasions during use.The following information was provided by the initial reporter: (1) anesthesia equipment without permeable lumen to pass medication, probably due to the lack of holes in the distal catheter.(2) of seven inspected primary containers, none presents the instructions for conservation.(3) of seven inspected parts, no filter is present.(4) of five inspected parts, no filter is present.
 
Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 6/22/2020.H.6.Investigation; a device history record review was performed for provided lot number 9025676.The review did not reveal any detected quality issues during the production process that could have contributed to this reported incident and all inspections were found to be within specification.To aid in the investigation of this issue, seven physical samples were returned for evaluation by our quality engineer team.The samples were visually inspected and no defects were observed.Each sample product had three holes per specification.None of the samples showed signs of occlusion through testing.As no defects were observed, a manufacturing related cause for the reported incident could not be determined.H3 other text : see h.10.
 
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Brand Name
PERISAFE I 17 X 3-1/2IN
Type of Device
CATHETER
Manufacturer (Section D)
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
periferico luis donaldo
colosio no. 579
nogales
MX 
MDR Report Key9644267
MDR Text Key194706771
Report Number9610847-2020-00026
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,Followup
Report Date 07/15/2020
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 Date02/01/2024
Device Catalogue Number405067
Device Lot Number9025676
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/22/2020
Initial Date Manufacturer Received 01/09/2020
Initial Date FDA Received01/29/2020
Supplement Dates Manufacturer Received01/09/2020
01/09/2020
Supplement Dates FDA Received05/06/2020
07/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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