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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 FULL KIT 20G X 10 CM WITH PROBE COVER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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C.R. BARD, INC. (BASD) -3006260740 FULL KIT 20G X 10 CM WITH PROBE COVER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number N/A
Device Problems Fluid/Blood Leak (1250); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/21/2022
Event Type  malfunction  
Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of regp3084 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported by healthcare professional "while doing bedside training with new vat member at facility, we noticed (while attempting to float powerglide catheter in) that the catheter either had a hole in it, or was slightly separated from the hub.As the vat member flushed it, it leaked, and when aspirating, you could hear the air almost sucking into the catheter, and see that the syringe was pulling air into it.".
 
Event Description
It was reported by healthcare professional "while doing bedside training with new vat member at facility, we noticed (while attempting to float powerglide catheter in) that the catheter either had a hole in it, or was slightly separated from the hub.As the vat member flushed it, it leaked, and when aspirating, you could hear the air almost sucking into the catheter, and see that the syringe was pulling air into it.".
 
Manufacturer Narrative
H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leaking catheter was confirmed.The product returned for evaluation was one 20ga x 10cm powerglide pro rt midline catheter.The catheter was removed from the insertion assembly and the assembly was not returned for evaluation.The catheter shaft exhibited curved shape memory and light usage residues were observed.An attempt to infuse water through the sample using a 12ml syringe revealed the sample to be patent to infusion; however, a leak was observed near the molded joint.Microscopic inspection of the leak site revealed a v-shaped split.The split exhibited sharply defined fracture features and a glossy veneer.A longitudinally aligned scoring mark was observed on the inside surface of the catheter wall leading into the fracture site from the side of the molded joint.The shape of the split, glossy texture and longitudinally aligned scoring mark were consistent with damage caused by contact between the catheter shaft and the introducer needle tip.Such damage can occur if the needle is re-inserted following catheter advancement and if the catheter is withdrawn onto the needle following catheter advancement.H3 other text : evaluation findings are in section h.11.
 
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Brand Name
FULL KIT 20G X 10 CM WITH PROBE COVER
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
johanna de oliveira
605 north 5600 west
salt lake city 84116
8015950700
MDR Report Key15033826
MDR Text Key299786806
Report Number3006260740-2022-02738
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00801741140631
UDI-Public(01)00801741140631
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162377
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,Followup
Report Date 08/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/15/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue NumberF220108PT
Device Lot NumberREGP3084
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/05/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/10/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2022
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) Other;
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