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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 PG PRO 22G 8CM BASIC KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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C.R. BARD, INC. (BASD) -3006260740 PG PRO 22G 8CM BASIC KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number N/A
Device Problem Break (1069)
Patient Problem Foreign Body In Patient (2687)
Event Date 04/10/2022
Event Type  Injury  
Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of reev2138 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported via medwatch "during placement of an ultrasound-guided iv, guidewire and catheter reportedly deployed without resistance.During wire retraction, issue noted with the device handle leading to destabilization of the guidewire and catheter hub.The plastic catheter detached from the catheter hub and was retained in patient's arm.".
 
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Brand Name
PG PRO 22G 8CM BASIC KIT
Type of Device
CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
C.R. BARD, INC. (BASD) -3006260740
605 north 5600 west
salt lake city 84116
Manufacturer (Section G)
BARD REYNOSA S.A. DE C.V. -9617592
blvd. montebello #1
parque industrial colonial
reynosa, tamaulipas 88780
MX   88780
Manufacturer Contact
kayla olsen
605 north 5600 west
salt lake city 84116
8015950700
MDR Report Key14461862
MDR Text Key292355330
Report Number3006260740-2022-01868
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00801741110542
UDI-Public(01)00801741110542
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K153280
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/02/2022
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 Health Professional
Device Model NumberN/A
Device Catalogue NumberF122080
Device Lot NumberREEV2138
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/28/2022
Initial Date FDA Received05/20/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/01/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age14 DA
Patient Weight4 KG
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