MAUDE Adverse Event Report: BASIC KIT 18G X10 CM WITH BIOPATCH; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Break (1069); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of refn0765 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "defective midline catheter broke off while attempting to insert midline catheter to left upper arm.2 cm plastic catheter tip lodged inside the dermis.Xray verified, dr.And patient notified." add info rcvd 06/18/2021: date of occurrence: 6/13/2021.Has the catheter tip been removed? if yes what date was it removed: not removed, md recommended to remove in outpatient ir.Was there additional medical intervention?: removal scheduled in outpatient ir.Was there patient harm reported?: no.
Event or Problem Description
It was reported "defective midline catheter broke off while attempting to insert midline catheter to left upper arm.2 cm plastic catheter tip lodged inside the dermis.Xray verified, dr.And patient notified." add info rcvd 06/18/2021: date of occurrence: (b)(6) 2021.Has the catheter tip been removed? if yes what date was it removed: not removed, md recommended to remove in outpatient ir.Was there additional medical intervention?: removal scheduled in outpatient ir.Was there patient harm reported?: no.
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 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 broken midline catheter was confirmed.The product returned for evaluation was one 18ga x 10cm powerglide pro midline catheter assembly.Usage residues were observed throughout the sample.The catheter was advanced and the safety mechanism was engaged over the needle tip.The catheter shaft was broken 7.6cm from the molded joint.The break exhibited a tapered profile.Microscopic inspection of the break revealed a partially glossy and partially dully granular break surface.A longitudinally aligned scoring mark was observed on the inside surface of the catheter leading into the break site.The break features were consistent with catheter damage caused either by withdrawal of the catheter or insertion of the needle following catheter advancement.The blood residues present on the device suggested that damage occurred during attempted device placement.The product ifu states ¿warning: once the catheter has been advanced, do not re-insert the needle back into 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 h11.

• Brand Name: BASIC KIT 18G X10 CM WITH BIOPATCH
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• MDR Report Key: 12131786
• Report Number: 3006260740-2021-02627
• Device Sequence Number: 3529843
• Product Code: FOZ
• UDI-Device Identifier: 00801741140518
• UDI-Public: (01)00801741140518
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K162377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2021

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: F318107T
• Device Lot Number: REFN0765
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2021
• Initial Date Received by Manufacturer: 06/15/2021
• Supplement Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 07/07/2021
• Supplement Report FDA Received Date: 08/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2021
• 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: Required Intervention
• Patient Age: 39 YR
• Patient Weight: 73