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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD POWERMIDLINE 4F SL 20 CM; MIDLINE CATHETER
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BARD POWERMIDLINE 4F SL 20 CM; MIDLINE CATHETER Back to Search Results
Catalog Number P6154118
Device Problem Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/23/2021
Event Type  malfunction  
Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of reey1781 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported: "when placing a midline a catheter the nurse encountered difficulties during the introduction of the dilator which is deformed.A bagged kit must have been used to mount the catheter.".
 
Event Description
It was reported: "when placing a midline a catheter the nurse encountered difficulties during the introduction of the dilator which is deformed.A bagged kit must have been used to mount the catheter.".
 
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 batch history, applicable previous investigation(s), labeling, applicable manufacturing records, sample analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of difficulty inserting the microintroducer/dilator/sheath was confirmed but the cause is unknown.The product returned for evaluation was a 4.5fr microintroducer/dilator/sheath.The dilator was still within the sheath and the sheath had not been peeled.The dilator was slightly bent and reddish residual material was seen within the lumen of the dilator, indicating that the device had been used.An area of deformation, where the material was bunched and slightly rolled under itself was seen on the sheath.The deformed section of the sheath was slightly flared away from the dilator.A longitudinal split was observed in the sheath material near the deformation.Dimensional analysis of the wall thickness of the sheath confirmed that it met the device specifications.The exact root cause of the damage could not be determined from evaluation of the sample.Possible contributing factors include insertion technique, steep insertion angle, and damage to the sheath prior to or during use.Manufacturing records were reviewed for this batch which did not reveal deviations or anomalies related to this event in regard to material, manufacturing, or packaging.The ifu states ¿advance the small sheath and dilator together as a unit over the guidewire, using a slight rotational motion.If necessary, a small incision may be made adjacent to the guidewire to facilitate insertion of the sheath and dilator.¿.
 
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Brand Name
BARD POWERMIDLINE 4F SL 20 CM
Type of Device
MIDLINE CATHETER
MDR Report Key12319064
MDR Text Key266442630
Report Number3006260740-2021-03317
Device Sequence Number1
Product Code PND
Combination Product (y/n)N
PMA/PMN Number
K153393
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 09/24/2021
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 Catalogue NumberP6154118
Device Lot NumberREEY1781
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/16/2021
Initial Date Manufacturer Received 07/23/2021
Initial Date FDA Received08/13/2021
Supplement Dates Manufacturer Received09/24/2021
Supplement Dates FDA Received09/29/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2020
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) Other;
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