MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERGLIDE MIDLINE CATHETER, 20G 8CM; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	M120080
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/21/2018
Type of Reportable Event	Serious Injury
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 reby0631 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the midline was being inserted via the brachial vein.The catheter broke during insertion and 7 cm of the catheter remained in the patient.The patient underwent a surgical procedure to have catheter removed.The patient did not incur any injury and is doing fine after his surgical procedure.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a broken powerglide midline catheter was confirmed; however, the root cause was not identified.The product returned for evaluation was one two photographs which depicted two 20ga x 8cm powerglide midline catheters.The first photograph depicted two catheters.The device on the left side appeared intact and free of evidence of use.The device on the right exhibited apparent usage residues.The device was placed next to a ruler and the catheter terminated approximately 1cm distal of the molded joint.The second photograph depicted a fragment of powerglide catheter tubing.Apparent usage residues were observed within the fragment.The fragment was placed next to a ruler and was approximately 7cm in length.The second photograph appeared to depict the fragment of catheter detached from the damaged device depicted in the first photograph.Inspection of the supplied photographs was not sufficient to identify the cause of the catheter breakage.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.Potential contributing factors include sharp instrument contact and retraction of the catheter against the introducer needle during device placement.No further action is required because the complainant event could not be related to a deficiency in product manufacture or deficiency while under correct product use.A lot history review (lhr) of reby0631 showed no other similar product complaint(s) from this lot number.(b)(4).
Event or Problem Description
It was reported that the midline was being inserted via the brachial vein.The catheter broke during insertion and 7 cm of the catheter remained in the patient.The patient underwent a surgical procedure to have catheter removed.The patient did not incur any injury and is doing fine after his surgical procedure.

• Brand Name: POWERGLIDE MIDLINE CATHETER, 20G 8CM
• 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: 7445484
• Report Number: 3006260740-2018-00758
• Device Sequence Number: 1718703
• Product Code: FOZ
• UDI-Device Identifier: 00801741075315
• UDI-Public: (01)00801741075315
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K121073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2018
• Report Date (Section F): 03/26/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: M120080
• Device Catalogue Number: M120080
• Device Lot Number: REBY0631
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2018
• Event Location: Hospital
• Date Report to Manufacturer: 03/26/2018
• Initial Date Received by Manufacturer: 04/12/2018
• Supplement Date Received by Manufacturer: 04/16/2018
• Initial Report FDA Received Date: 04/19/2018
• Supplement Report FDA Received Date: 05/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 86