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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION KIT

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ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION KIT Back to Search Results
Catalog Number FH-05500-J
Device Problem Cut In Material (2454)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/04/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device sample has not been returned for investigation at the time of this report. The manufacturer will continue to monitor and trend related events.
 
Event Description
Alleged event: after insertion of the catheter, when the nurse put tape on the patient's body, a cut was found in the catheter. As a result, the catheter was replaced by a new one. The patient's condition was reported as fine.
 
Manufacturer Narrative
(b)(4) a device history record review was performed on the catheter with no findings relevant to this complaint. The customer reported the catheter was discovered cut during use. The customer returned one epidural catheter, one snaplock adapter with clamp, and one flat filter. The snaplock adapter, filter, and piece of the separated catheter were received connected together (b)(4)). The catheter was returned separated in two pieces. The returned components were visually examined with and without margination. Visual examination of the returned snaplock adapter revealed that the snaplock appears typical with no observed defects or anomalies. Visual examination of the returned filter revealed that the filter appears typical with no observed defects or anomalies. Visual examination of the returned catheter revealed that the catheter appears used in that there is biological material present between the catheter coils. Microscopic examination revealed that the catheter appears to have been cut. The point of separation on either catheter piece shows no signs of stretching and the inner coil wire remains tightly wound). No other defects or anomalies were observed. Other remarks: the returned catheter pieces were measured ((b)(4)). The two catheter pieces measured approximately 50. 5cm & 40. 3cm. Specification per graphic (b)(4) indicates that the catheter length must be between 88. 5-91. 5 cm. The returned catheter pieces add up to a cumulative measurement of 90. 8cm. No signs of catheter stretching were present on the catheter extrusion or inner coils. This indicates the entire catheter was returned and no pieces are missing. Specifications per graphic (b)(4) were reviewed as a part of this complaint investigation. The ifu for this product,(b)(4) , was reviewed as a part of this complaint investigation. The ifu warns the user, "do not alter the catheter or any other kit/set component during insertion, use, or removal (except as instructed). " a corrective action is not required at this time as the condition of the sample received and the time of discovery indicate that use error caused or contributed to this event. The reported complaint of a cut catheter was confirmed based on the sample received. The returned catheter was returned in two pieces. The damage observed at the point of separation for both catheter pieces was consistent with a catheter that has been cut. The ifu for this kit, (b)(4), instructs the user not to alter the catheter. A device history record review was performed on the epidural catheter with no evidence to suggest a manufacturing related cause. Therefore, based upon the information provided, the observed catheter damage, and the time of discovery, use error caused or contributed to this event.
 
Event Description
Alleged event: after insertion of the catheter, when the nurse put tape on the patient's body, a cut was found in the catheter. As a result, the catheter was replaced by a new one. The patient's condition was reported as fine.
 
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Brand NameEPIDURAL CATHETERIZATION KIT
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL CR, A.S.
jamska 2359/47
zdar nad sazavou 591 0 1
EZ 591 01
Manufacturer Contact
jasmine brown
3015 carrington mill blvd
morrisville, NC 27560
9193614124
MDR Report Key5460210
MDR Text Key39450329
Report Number3006425876-2016-00049
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/04/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/25/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/30/2017
Device Catalogue NumberFH-05500-J
Device Lot Number71F15H0025
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/09/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/17/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/03/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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