MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 20 GAUGE POWERGLIDE PRO MIDLINE CATHETER 8CM 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 03/22/2022

Event Type  Injury  

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of refx4468 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported "midline broke off inside a patient resulting in the patient needing surgery." add information received 04/21/2022: a detailed description of the event: while removing, the midline broke off and became dislodged.How was the break and/or retained segment discovered? are radiographic images available? x-ray.Were all the missing/broken pieces retrieved and accounted for? yes, during surgery.What type of imaging was used to verify broken piece in patient? are pictures available? x-ray.What type of catheter securement was utilized? unknown, not documented.At what point during device use (i.E.Insertion, infusion, removal) did the break occur? removal.Any long-term patient harm? potential for infection.

Event Description

It was reported "midline broke off inside a patient resulting in the patient needing surgery." add information received 04/21/2022: a detailed description of the event: while removing, the midline broke off and became dislodged.How was the break and/or retained segment discovered? are radiographic images available? x-ray.Were all the missing/broken pieces retrieved and accounted for? yes, during surgery.What type of imaging was used to verify broken piece in patient? are pictures available? x-ray.What type of catheter securement was utilized? unknown, not documented.At what point during device use (i.E.Insertion, infusion, removal) did the break occur? removal.Any long-term patient harm? potential for infection.

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 damaged catheter was confirmed.The product returned for evaluation was one 20ga x 8cm powerglide pro midline catheter.The catheter shaft was broken near the molded joint.The proximal fragment, including the luer adapter, was not returned for evaluation.Curved shape memory and use residues were observed throughout the sample.Microscopic inspection of the break site revealed a partially granular and partially glossy fracture surface.The glossy region exhibited a striated texture.The fracture features were sharply defined.The fracture exhibited a tapered profile.The glossy striated region of the fracture surface suggested that damage was initiated through contact with a sharp instrument such as scissors or a scalpel.The location of the damage suggested that catheter securement or removal techniques may have contributed.H3 other text: evaluation findings are in section h11.

• Brand Name: 20 GAUGE POWERGLIDE PRO MIDLINE CATHETER 8CM 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: 14316382
• MDR Text Key: 291202315
• Report Number: 3006260740-2022-01667
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 07/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2022
• 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: F120080
• Device Lot Number: REFX4468
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2021
• 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
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 57 KG