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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION KIT; ANESTHESIA CONDUCTION CATHETER
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ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION KIT; ANESTHESIA CONDUCTION CATHETER Back to Search Results
Catalog Number CA-02220
Device Problems Crack (1135); Fluid/Blood Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/14/2020
Event Type  malfunction  
Manufacturer Narrative
Qn# (b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
 
Event Description
The report reads: from plexxus complaint form, had a faulty glass syringe last night which caused the patient to have a dural puncture; the hub was cracked and there was a small leak of saline.But then it was masked because the syringe plunger was stuck.The patient had a mild headache but did not require a blood patch.
 
Manufacturer Narrative
Qn#(b)(4).A device history record review was performed on the lor syringe with no relevant findings.The customer reported that the lor syringe hub was cracked and leaked.The customer returned one glass lor syringe and lidstock (reference attached files inp1900077633).The returned lor syringe was visually examined with and without magnification.Visual examination revealed that the metal hub has a crack.No other anomalies or defects were observed.The customer also provided a photo that shows a glass lor syringe.Functional testing was performed on the returned syringe using the lab leak tester (ref-002902) per the parameters in amrq-000128 rev.3, section 7.3-positive pressure leakage.Water was aspirated into the syringe to the 10ml mark and the syringe was inverted to remove any air from the barrel.The tip of the syringe was then connected to the lab leak tester via tubing and pressure was applied.A leak was detected coming from the crack in the hub, which was revealed during the visual inspection.No other leaks were detected.A corrective action is not required at this time as the root cause for this complaint investigation could not be determined based upon the information provided and the condition of the sample received.The reported complaint of the lor syringe having a crack in the hub causing a leak was confirmed based on the sample received.During visual examination of the returned lor syringe revealed the metal hub had a crack.During the functional inspection, a leak could be seen coming from the same location that was observed during visual examination.A device history record review was performed on the lor syringe with no relevant findings.It is unknown how the device was handled prior to and during use and the pressure used to inject is unknown.The investigation found no evidence to suggest a manufacturing related cause.Therefore, the potential cause of this complaint could not be determined.
 
Event Description
The report reads: from plexxus complaint form, had a faulty glass syringe last night which caused the patient to have a dural puncture; the hub was cracked and there was a small leak of saline.But then it was masked because the syringe plunger was stuck.The patient had a mild headache but did not require a blood patch.
 
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Brand Name
EPIDURAL CATHETERIZATION KIT
Type of Device
ANESTHESIA CONDUCTION CATHETER
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key10263450
MDR Text Key198599165
Report Number3011137372-2020-00148
Device Sequence Number1
Product Code BSO
Combination Product (y/n)N
PMA/PMN Number
K140110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 06/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/28/2022
Device Catalogue NumberCA-02220
Device Lot Number13F20B0539
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/25/2020
Initial Date Manufacturer Received 06/17/2020
Initial Date FDA Received07/13/2020
Supplement Dates Manufacturer Received08/05/2020
Supplement Dates FDA Received08/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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