MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 20 GAUGE POWERGLIDE PRO MIDLINE CATHETER 10CM BASIC KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/23/2022

Event Type  Injury  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of reft2241 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported the patient needed to get an midline.The nurse went in to the patient to insert an midline.After the nurse had inserted the catheter/needle in the patient and entered the vessel, the nurse tried to insert the leader.But the nurse got a big resistance.Then the nurse decided to end the attempt to pull out the catheter.When the nurse did that it was a big resistance.The nurse paused the attempt to remove the catheter and let the patient relax.After a while the nurse tried again to remove the midline.The wire was removed without any problems, but while the nurse was pulling out the plastic catheter the nurse heard that something was broken off and a piece of plastic catheter was missing from the end of the plastic catheter.They did a x-ray and the patient are waiting to get it out with surgery.

Event Description

It was reported the patient needed to get an midline.The nurse went in to the patient to insert an midline.After the nurse had inserted the catheter/needle in the patient and entered the vessel, the nurse tried to insert the leader.But the nurse got a big resistance.Then the nurse decided to end the attempt to pull out the catheter.When the nurse did that it was a big resistance.The nurse paused the attempt to remove the catheter and let the patient relax.After a while the nurse tried again to remove the midline.The wire was removed without any problems, but while the nurse was pulling out the plastic catheter the nurse heard that something was broken off and a piece of plastic catheter was missing from the end of the plastic catheter.They did a x-ray and the patient are waiting to get it out with surgery.

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, applicable previous investigation(s), sample analysis, applicable fmea documents, and applicable manufacturing records.Based on a review of this information, the following was concluded: the complaint of a break in the catheter was confirmed, but the exact cause could not be determined since the returned sample was incomplete.The distal end of the powerglide catheter was the only item returned for investigation.The catheter segment was 2.5cm in length.The tubing was kinked 6mm from the distal tip.A microscopic examination of the catheter tip revealed that the edge was deformed and rough.At the proximal end of the catheter segment, the contour of the cross section was uneven and came to a point.The observable features on the returned sample did not contain enough information to identify a specific root cause of the reported event.Potential contributing factors include complications during the insertion process and cutting the catheter on the needle tip; however, the exact cause of the observed damage could not be determined.A review of the inspection records and quality/manufacturing controls for the implicated lot indicated no issues with the manufacturing process.H3 other text: evaluation findings are in section h11.

• Brand Name: 20 GAUGE POWERGLIDE PRO MIDLINE CATHETER 10CM BASIC KIT
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 13978902
• MDR Text Key: 288518936
• Report Number: 3006260740-2022-01097
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K162377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/26/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 6F120100
• Device Lot Number: REFT2241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/09/2022
• Initial Date FDA Received: 04/01/2022
• Supplement Dates Manufacturer Received: 05/26/2022
• Supplement Dates FDA Received: 06/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention