MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 18 GAUGE POWERGLIDE PRO MIDLINE CATHETER; INTRAVASCULAR CATHETER

Model Number	N/A
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	05/30/2017
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) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
Per sales rep, the facility reported that two nurse assistants were helping to put a brief on the patient and reposition the patient in bed.The patient was instructed to put her arms on her chest.The iv pump with extension tubing was attached to the extension set of the midline and the tubing and pump were on the same side as the midline.It was stated there was enough slack in the iv tubing to reposition the patient.It was reported that an audible snap like breaking plastic was heard by the nurse assistant and the patient.The facility said neither of them could figure out what the snap was until the magnesium which was infusing via the midline began to come out of the broken extension set onto the nurse assistant¿s pants which became wet with medication.The nurse assistant called the nurse who clamped the midline and attached a new extension set.The midline dressing also had to be changed and the manipulation of the catheter led to the midline no longer working.This was the patient's only access and it was expressed that she was extremely difficult she could not receive her medications overnight.Facility reported the patient was unharmed in this event.6/9/17-additional information received stated: patient was receiving magnesium at time of incident.Had potassium the day before.Previous ivda, no issues while inpatient and was intubated most of the life of the midline.
Additional Manufacturer Narrative
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 break in the extension set tubing was confirmed, and, based on the event description, the cause was determined to be use related.Two photographs were returned for investigation.The physical sample was not returned for investigation.The photographs show a separation of the female luer adaptor from the extension set tubing.Instead of a complete separation of the tubing from the luer adaptor, it appears that the extension set tubing broke at or near the distal end of the connector.The fractured end of the extension set tubing exhibited an uneven surface.It was reported that the tubing inadvertently snapped when the nurses were repositioning the patient.
Event or Problem Description
Per sales rep, the facility reported that two nurse assistants were helping to put a brief on the patient and reposition the patient in bed.The patient was instructed to put her arms on her chest.The iv pump with extension tubing was attached to the extension set of the midline and the tubing and pump were on the same side as the midline.It was stated there was enough slack in the iv tubing to reposition the patient.It was reported that an audible snap like breaking plastic was heard by the nurse assistant and the patient.The facility said neither of them could figure out what the snap was until the magnesium which was infusing via the midline began to come out of the broken extension set onto the nurse assistant¿s pants which became wet with medication.The nurse assistant called the nurse who clamped the midline and attached a new extension set.The midline dressing also had to be changed and the manipulation of the catheter led to the midline no longer working.This was the patient's only access and it was expressed that she was extremely difficult she could not receive her medications overnight.Facility reported the patient was unharmed in this event.6/9/2017-additional information received stated: patient was receiving magnesium at time of incident.Had potassium the day before.Previous ivda, no issues while inpatient and was intubated most of the life of the midline.

• Brand Name: 18 GAUGE POWERGLIDE PRO MIDLINE CATHETER
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6663578
• Report Number: 3006260740-2017-00901
• Device Sequence Number: 603952
• Product Code: FOZ
• UDI-Device Identifier: 00801741110566
• UDI-Public: (01)00801741110566
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K162377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2017

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: F118101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 06/06/2017
• Supplement Date Received by Manufacturer: 06/28/2017
• Initial Report FDA Received Date: 06/23/2017
• Supplement Report FDA Received Date: 07/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Weight: 109