• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BARD POWERMIDLINE CATHETER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

C.R. BARD, INC. (BASD) -3006260740 BARD POWERMIDLINE CATHETER Back to Search Results
Model Number N/A
Device Problem Material Deformation (2976)
Patient Problem Unspecified Tissue Injury (4559)
Event Date 03/28/2023
Event Type  malfunction  
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 manufacturer has received the sample and will evaluate.Results are expected soon.
 
Event Description
It was reported by the customer that "introducer will not insert easily into vessel during picc procedure.Causing major trauma to vasculature".Additional information received 04/07/2023: opened another introducer kit and placed the line.There were no complications secondary to the vessel trauma.
 
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 complaint of a damaged microintroducer sheath is confirmed and was determined to be manufacturing related.One 4.5 fr x 7 cm microintroducer was returned for evaluation.An initial visual observation showed use residue on the returned sample.The distal end of the introducer sheath was observed to be damaged.A microscopic observation revealed a relatively large and straight spilt in the distal tip of the introducer sheath as well as two additional, smaller splits.Some plastic deformation was observed on one side of the large split; however, no deformation was observed on the other side of this split.The investigation was forwarded to the manufacturing facility for further evaluation, and bd is working closely with the manufacturing facility to prevent recurrence of the reported event.
 
Event Description
It was reported by the customer that "introducer will not insert easily into vessel during picc procedure.Causing major trauma to vasculature".Additional information received 04/07/2023: opened another introducer kit and placed the line.There were no complications secondary to the vessel trauma.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BARD POWERMIDLINE CATHETER
Type of Device
MIDLINE CATHETER
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 Key16769491
MDR Text Key313822952
Report Number3006260740-2023-01425
Device Sequence Number1
Product Code PND
UDI-Device Identifier00801741223945
UDI-Public(01)00801741223945
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNK
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 06/07/2023
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 Date03/31/2024
Device Model NumberN/A
Device Catalogue NumberCK001029
Device Lot NumberREGX0443
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/31/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/29/2023
Initial Date FDA Received04/19/2023
Supplement Dates Manufacturer Received06/07/2023
Supplement Dates FDA Received06/13/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2022
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;
-
-