MAUDE Adverse Event Report: BASIC KIT 18G X 8 CM WITH GAURDIVA; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	F118087T
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of reen2093 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by placer "this midline came apart on me today when i was advancing the catheter.It was an easy stick, did it just like i always do, and when i was pulling the needle out the whole thing came apart." additional information received 02/02/2021: "i have placed hundreds of powerglide midlines.In this instance, i found a large, easy vessel to access, accessed the vessel without difficulty, the guidewire slid forward without difficulty, the wings/ catheter slid in over wire easily.When i pulled back to enable safety mechanism, guidewire and handle came out of cork/end of catheter, but the needle and blood collection/needle cover remained in place/came apart from the rest of the mechanism.
Event or Problem Description
It was reported by placer "this midline came apart on me today when i was advancing the catheter.It was an easy stick, did it just like i always do, and when i was pulling the needle out the whole thing came apart." additional information received 02/02/2021: "i have placed hundreds of powerglide midlines.In this instance, i found a large, easy vessel to access, accessed the vessel without difficulty, the guidewire slid forward without difficulty, the wings/ catheter slid in over wire easily.When i pulled back to enable safety mechanism, guidewire and handle came out of cork/end of catheter, but the needle and blood collection/needle cover remained in place/came apart from the rest of the mechanism.
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 powerglide pro needle detachment was confirmed; however, the root cause was not identified.The product returned for evaluation was one 18ga powerglide midline catheter assembly.The catheter had been advanced and the safety mechanism was in place over the needle tip.The catheter was not returned.Usage residues were observed throughout the sample.The introducer needle was completely detached from the needle carrier.Microscopic inspection of the needle carrier did not reveal any obvious deformation.The lack of deformation suggested that needle detachment occurred with minimal mechanical stress.Photographs of the sample have been forwarded to the manufacturing site for further evaluation.

• Brand Name: BASIC KIT 18G X 8 CM WITH GAURDIVA
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• MDR Report Key: 11369308
• Report Number: 3006260740-2021-00454
• Device Sequence Number: 17285146
• Product Code: FOZ
• UDI-Device Identifier: 00801741140457
• UDI-Public: (01)00801741140457
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 08/11/2021

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
• Operator of Device: Health Professional
• Device Model Number: F118087T
• Device Catalogue Number: F118087T
• Device Lot Number: REEN2093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2021
• Initial Date Received by Manufacturer: 01/27/2021
• Supplement Date Received by Manufacturer: 08/11/2021
• Initial Report FDA Received Date: 02/23/2021
• Supplement Report FDA Received Date: 09/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2020
• 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 Age: 28 YR
• Patient Weight: 58