MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERGLIDE ST MIDLINE CATHETER MAXIMAL BARRIER KIT (18G) (10CM)

Model Number	N/A
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer, "we have a nurse that placed a midline on a patient.She used the st kit, with the introducer/wire.When placing midline, she accessed the vein and advanced the wire as normal.She placed the midline/introducer combo on the end of the wire and advanced into place appropriately.She then withdrew the wire, while leaving the introducer in place.The extension tubing was hooked up to the end of the introducer and the midline was used this way, with the introducer in place.A few days into the dwell time, a floor nurse noticed it was flushing sluggishly and was having difficulty with blood draw.When the iv team nurse went to assess the midline, she noted the white introducer piece was in place with the extension hooked up to the introducer.When removing midline, she also noted the introducer in place at the tip." additional information received on october 21, 2024: it was reported date of event was 10/13/2024.Midline was flushing with resistance, so line was pulled.The introducer was found to be in place still.Due to patient being difficult intravenous access and having the midline pulled, patient had a jugular central line placed.
Additional 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 it will be evaluated.A supplemental will be submitted with evaluation results.
Additional 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 the dilator being left in place following catheter placement, resulting in reduced catheter performance was confirmed and the cause appeared to be use-related.The product returned for evaluation was two photographs which depict an 18 ga x 8 cm powerglide pro midline catheter.The first photograph depicted the catheter with the extension set attached.The dilator remained inserted through the catheter, and the extension set male luer adapter was attached to the dilator.The photograph depicted failure to remove the inlaid vessel dilator prior to attachment of the extension set.The dilator should be removed along with the guidewire during the catheter insertion process, prior to attachment of the extension set and normal use of the indwelling catheter.
Event or Problem Description
It was reported by the customer, "we have a nurse that placed a midline on a patient.She used the st kit, with the introducer/wire.When placing midline, she accessed the vein and advanced the wire as normal.She placed the midline/introducer combo on the end of the wire and advanced into place appropriately.She then withdrew the wire, while leaving the introducer in place.The extension tubing was hooked up to the end of the introducer and the midline was used this way, with the introducer in place.A few days into the dwell time, a floor nurse noticed it was flushing sluggishly and was having difficulty with blood draw.When the iv team nurse went to assess the midline, she noted the white introducer piece was in place with the extension hooked up to the introducer.When removing midline, she also noted the introducer in place at the tip." additional information received on october 21, 2024: it was reported date of event was 10/13/24.Midline was flushing with resistance, so line was pulled.The introducer was found to be in place still.Due to patient being difficult intravenous access and having the midline pulled, patient had a jugular central line placed.

• Brand Name: POWERGLIDE ST MIDLINE CATHETER MAXIMAL BARRIER KIT (18G) (10CM)
• Common Device Name: 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: kayla bevins ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 20654692
• Report Number: 3006260740-2024-06559
• Device Sequence Number: 15482443
• Product Code: PND
• UDI-Device Identifier: 00801741139291
• UDI-Public: (01)00801741139291(11)240906(17)251231(10)REJU1044
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K170158
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2025
• Device Model Number: N/A
• Device Catalogue Number: ST118101
• Device Lot Number: REJU1044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2024
• Supplement Date Received by Manufacturer: 01/30/2025
• Initial Report FDA Received Date: 11/11/2024
• Supplement Report FDA Received Date: 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown