MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERGLIDE MIDLINE CATHETER, 18G 10CM; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	M118100
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided by bard 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 bard.The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of recn1704 showed one other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported via sales rep from facility that "mid line was being placed in the cephalic vein, wire would not deploy due to resistance met , wire did not lock into place due to resistance met immediately, wire was pulled back and catheter was repositioned via ultra sound guidance, wire deployed and catheter advanced without resistance, catheter would not flush and was pulled out, distal tip of catheter kinked approximately 1 cm from the end of the catheter.".
Additional Manufacturer Narrative
The initial complaint appeared to be a reportable occurrence.Once the sample was returned and evaluated it was determined that a reportable event had not occurred.The returned sample exhibited no evidence of the alleged event.The event is unconfirmed per the investigation results.Since no device malfunction occurred and there is no allegation of a serious injury to a patent, user, or other person, this event is deemed not reportable per 21 cfr part 803.
Event or Problem Description
It was reported via sales rep from facility that "mid line was being placed in the cephalic vein, wire would not deploy due to resistance met , wire did not lock into place due to resistance met immediately, wire was pulled back and catheter was repositioned via ultra sound guidance, wire deployed and catheter advanced without resistance, catheter would not flush and was pulled out, distal tip of catheter kinked approximately 1 cm from the end of the catheter.".

• Brand Name: POWERGLIDE MIDLINE CATHETER, 18G 10CM
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7811517
• Report Number: 3006260740-2018-02213
• Device Sequence Number: 1517856
• Product Code: FOZ
• UDI-Device Identifier: 00801741038105
• UDI-Public: (01)00801741038105
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K133856
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2018

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: M118100
• Device Catalogue Number: M118100
• Device Lot Number: RECN1704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 08/16/2018
• Supplement Date Received by Manufacturer: 09/13/2018
• Initial Report FDA Received Date: 08/23/2018
• Supplement Report FDA Received Date: 09/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 71