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

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned, at this time, to the manufacturer for evaluation.A lot history review (lhr) of recw0170 showed four other similar product complaint(s) from this lot number.The complaints for this lot number (recw0170) have been reported from the same facility.Device has not yet been returned for evaluation.
Event or Problem Description
It was reported that extension set came apart at connection between luer device and tubing on the powerglide, causing blood leakage.This report addresses the fifth device.
Additional Manufacturer Narrative
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, frequency 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 detached hub is confirmed and was determined to be supplier related.One extension tubing set was returned for evaluation.An initial visual observation showed the distal luer hub was detached from the extension tubing.Use and adhesive residue was observed throughout the returned sample.A microscopic observation revealed striations on the distal end of the extension tubing, which had slightly polished edges, suggesting it is the manufactured end.No tubing was observed within the detached luer hub and no mechanical damage was observed on the tubing or the detached luer connector.Some adhesive was observed on the surface of the tubing in the region the luer hub would have been positioned.An incident report was issued to notify the supplier.A lot history review (lhr) of recw0170 showed four other similar product complaint(s) from this lot number.The complaints for this lot number (recw0170) have been reported from the same facility.
Event or Problem Description
It was reported that extension set came apart at connection between luer device and tubing on the powerglide, causing blood leakage.This report addresses the fifth device.

• Brand Name: POWERGLIDE MIDLINE CATHETER FULL 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: 8337792
• Report Number: 3006260740-2019-00247
• Device Sequence Number: 19390549
• Product Code: FOZ
• UDI-Device Identifier: 00801741038075
• UDI-Public: (01)00801741038075
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K121073
• 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): 05/10/2019

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: M120101
• Device Lot Number: RECW0170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 01/20/2019
• Supplement Date Received by Manufacturer: 05/07/2019
• Initial Report FDA Received Date: 02/13/2019
• Supplement Report FDA Received Date: 05/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1