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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERGLIDE PRO MIDLINE 20GX8CM; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
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C.R. BARD, INC. (BASD) -3006260740 POWERGLIDE PRO MIDLINE 20GX8CM; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number F120080T
Device Problems Break (1069); Failure to Advance (2524)
Patient Problem Foreign Body In Patient (2687)
Event Date 09/10/2020
Event Type  Injury  
Manufacturer Narrative
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 is pending evaluation.Results are expected soon.A lot history review (lhr) of reep4157 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported via medwatch "midline catheter was being placed via ultrasound and when rn unable to get a blood return or positive placement verification with the wire advancement, the catheter was removed.Upon inspection of the catheter, the 2cm tip of the poly catheter was missing.Repeat elbow x-ray taken on (b)(6)2020 and a foreign body noted in the same place.".
 
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 powerglide midline catheter was confirmed.The product returned for evaluation was one 20ga x 8cm powerglide pro midline catheter assembly.Usage residues were observed throughout the sample.The catheter was advanced and the safety mechanism was engaged.The catheter terminated 6.2cm from the molded joint.The break site appeared irregular.Microscopic inspection of the break in the catheter revealed a partially granular and partially glossy fracture surface.The break exhibited a tapered profile.A longitudinally aligned scoring mark was observed in the inner wall of the catheter, leading into the break site.The catheter fracture features and the longitudinal scoring mark were consistent with damage caused by contact between the catheter shaft and the needle tip.The use residues indicated that contact occurred during attempted device placement.Such damage can occur if the catheter is withdrawn onto the needle following advancement and if the needle is reinserted.The product ifu states ¿warning: once the catheter has been advanced, do not re-insert the needle back onto the catheter or pull the catheter back onto the needle.If the catheter needs to be repositioned, either do so without the aid of the needle, or remove both the catheter and the needle as a unit to prevent the needle from damaging or shearing the catheter.¿ h3 other text: evaluation findings are in section h.11.
 
Event Description
It was reported via medwatch "midline catheter was being placed via ultrasound and when rn unable to get a blood return or positive placement verification with the wire advancement, the catheter was removed.Upon inspection of the catheter, the 2cm tip of the poly catheter was missing.Repeat elbow x-ray taken on (b)(6) 2020 and a foreign body noted in the same place.".
 
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Brand Name
POWERGLIDE PRO MIDLINE 20GX8CM
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
MDR Report Key10788539
MDR Text Key214721455
Report Number3006260740-2020-20387
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00801741142666
UDI-Public(01)00801741142666
Combination Product (y/n)N
PMA/PMN Number
K162377
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 12/17/2020
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 Expiration Date01/31/2022
Device Model NumberF120080T
Device Catalogue NumberF120080T
Device Lot NumberREEP4157
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/26/2020
Initial Date Manufacturer Received 10/12/2020
Initial Date FDA Received11/04/2020
Supplement Dates Manufacturer Received12/17/2020
Supplement Dates FDA Received01/13/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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