MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERGLIDE ST MIDLINE CATHETER MAXIMAL BARRIER KIT (20G) (10CM); CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	12/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of redt4147 showed one other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the powerglide was inserted on (b)(6) 2019 in ac of combative patient.Rn flushed catheter on (b)(6) 2019 and noticed pinhole in exposed part of catheter.Bodily fluid sprayed in face of rn upon flushing.Rn underwent testing to eliminate risk of transmission.The catheter was removed.
Event or Problem Description
It was reported that the powerglide was inserted on (b)(6) 2019 in ac of combative patient.Rn flushed catheter on (b)(6) 2019 and noticed pinhole in exposed part of catheter.Bodily fluid sprayed in face of rn upon flushing.Rn underwent testing to eliminate risk of transmission.The catheter was removed.Additional information-1/31/2020: it was stated, "no one was harmed in this incident.".
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 leaking powerglide was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 20ga x 10cm powerglide rt midline catheter.Usage residues were observed throughout the sample.An extension set was attached to the luer adapter.Curved shape memory was observed along the length of the catheter.A permanent kink was observed just distal of the molded joint.A circumferentially aligned split was observed at one corner of the kink.Microscopic inspection of the split revealed a granular fracture surface.Material buckling and discoloration were observed in the vicinity of the split.The split appeared to have been caused by sharp kinking of the catheter tubing.The abundant usage residues indicated that kinking occurred during device use, and the location suggested that catheter securement, access and maintenance techniques may have contributed.A lot history review (lhr) of redt4147 showed one other similar product complaint(s) from this lot number.

• Brand Name: POWERGLIDE ST MIDLINE CATHETER MAXIMAL BARRIER KIT (20G) (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: 9650088
• Report Number: 3006260740-2020-00325
• Device Sequence Number: 3135408
• Product Code: LJS
• UDI-Device Identifier: 00801741139376
• UDI-Public: (01)00801741139376
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K170158
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2020

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: N/A
• Device Catalogue Number: ST020101D
• Device Lot Number: REDT4147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 01/08/2020
• Supplement Date Received by Manufacturer: 03/10/2020
• Initial Report FDA Received Date: 01/30/2020
• Supplement Report FDA Received Date: 03/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1