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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC 4F NURSE BASIC TRAY WITH MICROINTRODUCER (SINGLE-LUMEN); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
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C.R. BARD, INC. (BASD) -3006260740 POWERPICC 4F NURSE BASIC TRAY WITH MICROINTRODUCER (SINGLE-LUMEN); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS Back to Search Results
Model Number N/A
Device Problem Fluid/Blood Leak (1250)
Patient Problem Infiltration into Tissue (1931)
Event Date 06/27/2022
Event Type  malfunction  
Event Description
It was reported that extravasation occurred at the insertion site when the catheter in this patient was being maintained.Due to the concern about potential problems in the future use, the customer removed the catheter.An examination showed that the catheter was severely damaged at the scale of 14.5cm.
 
Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of refw2427 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (refw2427) have been reported from facility china.
 
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 damaged catheter was confirmed; however, the root cause was not identified.The product returned for evaluation was one photograph which depicted a 4fr s/l powerpicc catheter.The depicted region included a segment of catheter shaft.A partially circumferential split was observed.Depth marking wear, curved shape memory, buckling and discoloration were observed in the vicinity of the split.The catheter features in the vicinity of the fracture suggested that cyclic kinking of the catheter contributed to the catheter damage; however, it could not be determined if an additional unidentified factor(s) also contributed.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.H3 other text : evaluation findings are in section h.11.
 
Event Description
It was reported that extravasation occurred at the insertion site when the catheter in this patient was being maintained.Due to the concern about potential problems in the future use, the customer removed the catheter.An examination showed that the catheter was severely damaged at the scale of 14.5cm.
 
Event Description
It was reported that extravasation occurred at the insertion site when the catheter in this patient was being maintained.Due to the concern about potential problems in the future use, the customer removed the catheter.An examination showed that the catheter was severely damaged at the scale of 14.5cm.
 
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, complaint and lot history review, applicable previous investigation(s), sample (if available), applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leak was confirmed.The product returned for evaluation was one 4 fr single lumen powerpicc catheter.The investigation findings are consistent with damage accumulated through flexural fatigue.Flexural fatigue occurs due to cyclic kinking of the catheter tube in which physiological, placement, usage, and mechanical factors may gradually form a crack(s) in the catheter.The returned product sample was evaluated, and a large split was observed approximately 15.5 cm distal to molded joint.The catheter split contained physical features associated with material fatigue, and the characteristics observed which supported this type of failure included: damage which was circumferentially aligned fracture edges which were rounded and polished due to repeated material wear 'c' shaped impressions leading into the fracture site which are consistent with material buckling due to movement which caused the fracture edges to be pressed together overall elliptical shape to the fracture cross-section (a result of repeated kinking of the tubing).An examination of the catheter structure revealed no potential damage/defect related to manufacture of the product.H3 other text : evaluation findings are in section h.11.
 
Event Description
It was reported that extravasation occurred at the insertion site when the catheter in this patient was being maintained.Due to the concern about potential problems in the future use, the customer removed the catheter.An examination showed that the catheter was severely damaged at the scale of 14.5cm.On (b)(6) 2023, defective product exhibited catheter discoloration problem.
 
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.
 
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Brand Name
POWERPICC 4F NURSE BASIC TRAY WITH MICROINTRODUCER (SINGLE-LUMEN)
Type of Device
CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER 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
becky garcia
605 north 5600 west
salt lake city 84116
8015950700
MDR Report Key15033921
MDR Text Key300908030
Report Number3006260740-2022-02747
Device Sequence Number1
Product Code LJS
UDI-Device Identifier00801741027598
UDI-Public(01)00801741027598
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K070996
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,Followup,Followup,Followup
Report Date 01/23/2024
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 Number3174118
Device Lot NumberREFW2427
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/30/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/19/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2021
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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